A Phase 1/2 interventional study of ACI-35.030 and ACI-35.030 in Alzheimer's Disease, Cognitive Impairment and Tauopathies, sponsored by AC Immune SA. Completed at 9 sites in 4 countries. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by AC Immune SA · Phase 1/2, Interventional, and Treatment
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 57 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →AC Immune SA is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo administered at predefined time points over a 48-week period.
Other: Placebo
Active vaccine administered at predefined time points over a 48-week period.
Biological: ACI-35.030
Active vaccine administered at predefined time points over a 48-week period.
Biological: ACI-35.030
Active vaccine administered at predefined time points over a 48-week period.
Biological: ACI-35.030
Active vaccine administered at predefined time points over a 48-week period.
Biological: JACI-35.054
Active vaccine administered at predefined time points over a 48-week period.
Biological: JACI-35.054
Administration of a Low dose of ACI-35.030
Administration of a Medium dose of ACI-35.030
Administration of a High dose of ACI-35.030
Administration of Placebo
Administration of a Low dose of JACI-35.054
Administration of a Medium dose of JACI-35.054
Overview of Treatment-Emergent Adverse Events, Safety Set
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
Time frame: AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities. * Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health * Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health Although subjects may have experienced multiple events, they are included only once, in the maximum severity category
Time frame: Between the first dosing and the last study visit (week 74)
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Unrelated: Events reported as unrelated or unlikely related to study drug * Related: Events reported as possibly related or probably related to study drug Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category
Time frame: Between the first dosing and the last study visit (week 74)
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Mean Change From Baseline in Heart Rate, ITT Set
At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Mean Change From Baseline in Body Temperature, ITT Set
At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject.
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.
Number of Participants With Abnormal MRI Results, ITT Set
Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported.
Time frame: Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Change From Baseline of Functional Performance Using CDR-SB Scale
CDR-SB means Clinical Dementia Rating - Sum of Boxes. The score ranges from 0 to 18. A higher score indicates a worse outcome.
Time frame: from baseline up to week 74
Change From Baseline of Cognitive Performance Using RBANS Scale
RBANS means Repeatable Battery for the Assessment of Neuropsychological Status. The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.
Time frame: from baseline up to week 74
Change From Baseline of Behavior Using NPI Scale
NPI means Neuropsychiatric Inventory. The score ranges from 0 to 144. A higher score indicates a worse outcome.
Time frame: from baseline up to week 74
Recruitment was performed in Finland, the Netherlands, Sweden and the UK. 79 subjects were screened for the study; 22 subjects did not meet the eligibility criteria; 1 subject was re-screened and qualified to participate.
| Milestone | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Started | 6 | 19 | 6 | 10 | 6 | 6 | 4 |
| Completed | 4 | 17 | 5 | 10 | 6 | 6 | 4 |
| Not completed | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Subject withdrawal by caregiver | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
| Participants | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Any TEAE | 6 | 17 | 6 | 8 | 6 | 6 | 4 |
| Any Serious TEAE | 2 | 2 | 2 | 0 | 0 | 0 | 1 |
| Any Severe TEAE | 1 | 2 | 0 | 0 | 0 | 0 | 1 |
| Any Adverse Drug Reactions | 3 | 15 | 6 | 2 | 4 | 2 | 0 |
| Any Serious Adverse Drug Reactions | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Any TEAE Leading to Study Drug Discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any TEAE Leading to Study Discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any TEAE with Outcome of Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities. * Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health * Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health Although subjects may have experienced multiple events, they are included only once, in the maximum severity category
| Participants | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Mild | 2 | 8 | 3 | 4 | 3 | 1 | 2 |
| Moderate | 3 | 7 | 3 | 4 | 3 | 5 | 1 |
| Severe | 1 | 2 | 0 | 0 | 0 | 0 | 1 |
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Unrelated: Events reported as unrelated or unlikely related to study drug * Related: Events reported as possibly related or probably related to study drug Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category
| Participants | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Unrelated | 3 | 2 | 0 | 6 | 2 | 4 | 4 |
| Related | 3 | 15 | 6 | 2 | 4 | 2 | 0 |
At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
| mmHg | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Change from baseline to Week 26 | -6.00 ± NA | 2.47 ± 8.790 | 3.67 ± 5.989 | 2.00 ± 7.578 | -5.00 ± 3.795 | -3.17 ± 7.627 | -8.25 ± 14.500 |
| Change from baseline to Week 50 | -6.75 ± 2.500 | -0.33 ± 6.334 | 5.20 ± 9.203 | -4.20 ± 6.713 | -1.83 ± 5.037 | -2.50 ± 5.167 | -5.00 ± 8.602 |
| Change from baseline to Week 74 | -3.75 ± 5.377 | 4.76 ± 8.511 | 1.60 ± 5.857 | 0.40 ± 7.412 | -3.33 ± 6.947 | -3.33 ± 4.227 | -1.25 ± 11.325 |
At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
| mmHg | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Change from baseline to Week 26 | -15.00 ± NA | 4.11 ± 16.773 | 9.33 ± 8.335 | 1.38 ± 11.388 | -3.17 ± 9.411 | 3.50 ± 8.550 | -3.75 ± 27.861 |
| Change from baseline to Week 50 | -5.25 ± 13.647 | -1.83 ± 19.242 | 9.20 ± 9.859 | -2.50 ± 14.393 | 1.33 ± 17.535 | 0.67 ± 5.574 | -1.75 ± 23.243 |
| Change from baseline to Week 74 | -3.75 ± 15.457 | -1.00 ± 19.082 | 6.60 ± 15.421 | -1.60 ± 21.035 | 0.67 ± 17.014 | -2.83 ± 7.195 | 3.75 ± 27.208 |
At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
| bpm | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Change from baseline to Week 26 | -2.00 ± NA | -4.11 ± 9.225 | -1.17 ± 9.948 | -4.38 ± 11.649 | -1.83 ± 7.494 | -0.33 ± 4.885 | -10.00 ± 11.888 |
| Change from baseline to Week 50 | -5.75 ± 4.193 | -2.61 ± 7.935 | -2.80 ± 7.596 | -0.30 ± 9.019 | -6.00 ± 5.762 | -3.00 ± 6.633 | -7.25 ± 11.558 |
| Change from baseline to Week 74 | 2.25 ± 6.752 | 1.41 ± 8.675 | -7.40 ± 7.232 | 1.90 ± 13.674 | -6.17 ± 3.920 | -0.67 ± 7.967 | -10.25 ± 14.728 |
At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
| °C | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Change from baseline to Week 26 | -0.40 ± NA | 0.02 ± 0.617 | 0.03 ± 0.367 | 0.19 ± 0.360 | 0.12 ± 0.781 | 0.02 ± 0.462 | 0.30 ± 0.497 |
| Change from baseline to Week 50 | 0.03 ± 0.299 | 0.18 ± 0.451 | -0.04 ± 0.532 | 0.36 ± 0.357 | -0.08 ± 0.880 | -0.47 ± 0.266 | 0.05 ± 0.635 |
| Change from baseline to Week 74 | 0.08 ± 0.171 | 0.13 ± 0.625 | -0.18 ± 0.383 | 0.29 ± 0.623 | 0.00 ± 0.555 | -0.35 ± 0.367 | 0.15 ± 0.436 |
Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject.
| Participants | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Suicidal ideation or behavior - Baseline — No | 6 | 19 | 6 | 10 | 6 | 6 | 4 |
| Suicidal ideation or behavior - Baseline — Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Suicidal ideation or behavior - Week 26 — No | 3 | 19 | 6 | 10 | 6 | 6 | 4 |
| Suicidal ideation or behavior - Week 26 — Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Suicidal ideation or behavior - Week 50 — No | 4 | 18 | 5 | 10 | 5 | 6 | 4 |
| Suicidal ideation or behavior - Week 50 — Yes | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Suicidal ideation or behavior - Week 74 — No | 4 | 17 | 5 | 10 | 6 | 6 | 4 |
| Suicidal ideation or behavior - Week 74 — Yes | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported.
| Participants | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Baseline — Normal | 5 | 17 | 6 | 10 | 5 | 6 | 4 |
| Baseline — Abnormal NCS | 1 | 2 | 0 | 0 | 1 | 0 | 0 |
| Baseline — Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Baseline — Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 10 — Normal | 6 | 16 | 6 | 10 | 6 | 6 | 4 |
| Week 10 — Abnormal NCS | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Week 10 — Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 10 — Not evaluable | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Week 26 — Normal | 1 | 17 | 6 | 7 | 6 | 6 | 4 |
| Week 26 — Abnormal NCS | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Week 26 — Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 26 — Not evaluable | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Week 50 — Normal | 4 | 17 | 5 | 10 | 6 | 5 | 4 |
| Week 50 — Abnormal NCS | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Week 50 — Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 50 — Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 74 — Normal | 3 | 15 | 5 | 10 | 6 | 4 | 3 |
| Week 74 — Abnormal NCS | 0 | 2 | 0 | 0 | 0 | 2 | 1 |
| Week 74 — Abnormal CS | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Week 74 — Not evaluable | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
| AU/mL | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Baseline | 2048.4 (1155.4 to 3631.6) | 994.6 (688.7 to 1436.5) | 676.2 (476.0 to 960.6) | 802.4 (713.5 to 902.2) | 913.9 (619.4 to 1348.4) | 1073.3 (808.9 to 1424.1) | 981.7 (711.2 to 1354.9) |
| Week 2 | 80292.0 (37517.3 to 171835.3) | 158154.6 (86332.2 to 289728.2) | 187980.6 (99157.0 to 356371.2) | 811.0 (714.5 to 920.5) | 1403.8 (1065.4 to 1849.6) | 5286.1 (1053.3 to 26530.2) | 895.4 (598.7 to 1339.2) |
| Week 8 | 49360.9 (19121.1 to 127424.7) | 92181.7 (56336.9 to 150833.0) | 66035.9 (37536.0 to 116174.9) | 768.6 (684.5 to 863.1) | 3054.4 (1875.2 to 4975.1) | 6928.5 (2386.1 to 20118.9) | 971.5 (668.5 to 1412.0) |
| Week 10 | 110984.4 (31648.6 to 389197.3) | 182111.4 (113522.2 to 292141.7) | 135520.1 (71679.7 to 256219.1) | 749.7 (652.5 to 861.4) | 105042.6 (39205.0 to 281442.5) | 82513.4 (34350.2 to 198207.6) | 969.2 (671.7 to 1398.6) |
| Week 24 | 6900.0 (NA to NA) | 32248.7 (19704.9 to 52777.7) | 19853.3 (10110.8 to 38983.4) | 1056.1 (860.3 to 1296.6) | 27519.3 (11321.5 to 66891.5) | 27030.2 (11647.9 to 62726.3) | 789.4 (524.8 to 1187.3) |
| Week 26 | 21800.0 (NA to NA) | 71385.3 (43249.5 to 117824.7) | 60104.8 (26253.5 to 137603.9) | 1136.8 (913.4 to 1414.8) | 329361.3 (136886.4 to 792473.2) | 123787.7 (85919.6 to 178345.7) | 919.5 (646.4 to 1308.0) |
| Week 36 | 8207.3 (3347.2 to 20124.4) | 30141.2 (17057.1 to 53261.7) | 19810.7 (9322.3 to 42099.2) | 571.6 (373.6 to 874.5) | 127585.6 (64839.7 to 251051.1) | 58190.1 (43600.4 to 77661.9) | 1245.1 (728.7 to 2127.6) |
| Week 48 | 5408.4 (2873.1 to 10181.1) | 17533.0 (9904.6 to 31036.7) | 10848.2 (4285.7 to 27459.9) | 676.2 (523.4 to 873.7) | 56549.1 (28051.0 to 113999.4) | 25968.2 (18637.2 to 36182.9) | 1137.1 (599.1 to 2158.2) |
| Week 50 | 86662.7 (22301.9 to 336760.7) | 54164.6 (28561.9 to 102717.6) | 63735.9 (38946.7 to 104303.4) | 617.0 (464.4 to 819.7) | 408403.6 (273922.2 to 608908.1) | 137934.8 (61731.7 to 308205.1) | 1311.8 (750.6 to 2292.6) |
| Week 67 | 14623.7 (7565.4 to 28267.4) | 17464.2 (8728.8 to 34941.7) | 10128.3 (5232.7 to 19604.1) | 714.1 (555.9 to 917.2) | 144349.8 (92815.9 to 224496.7) | 47764.4 (20377.3 to 111959.5) | 681.2 (451.3 to 1028.0) |
| Week 74 | 10527.5 (6075.0 to 18243.5) | 15301.0 (7889.7 to 29673.9) | 8565.4 (3914.9 to 18740.2) | 719.1 (577.5 to 895.5) | 107038.5 (63784.9 to 179623.2) | 31817.4 (11556.3 to 87601.2) | 682.9 (468.2 to 995.9) |
At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
| AU/mL | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Baseline | 1553.4 (1116.9 to 2160.5) | 2515.4 (1449.4 to 4365.5) | 1691.8 (862.3 to 3319.3) | 2006.5 (1120.3 to 3593.7) | 2659.9 (1508.2 to 4691.1) | 2027.6 (1551.2 to 2650.4) | 2754.4 (1696.8 to 4471.2) |
| Week 2 | 4147.0 (1790.9 to 9602.7) | 8245.3 (5162.3 to 13169.5) | 4132.5 (2007.6 to 8506.3) | 2270.6 (1276.5 to 4038.9) | 2419.2 (1263.7 to 4631.6) | 2128.4 (1371.1 to 3303.9) | 2680.9 (1514.7 to 4745.2) |
| Week 8 | 4281.7 (2522.5 to 7267.8) | 7928.5 (5215.6 to 12052.4) | 3973.2 (2439.9 to 6469.9) | 1992.7 (1095.7 to 3624.2) | 2904.3 (1461.7 to 5770.6) | 2270.4 (1289.0 to 3999.3) | 2682.9 (1663.9 to 4326.0) |
| Week 10 | 9371.5 (3398.3 to 25843.8) | 17848.1 (11623.1 to 27406.9) | 9317.6 (5404.3 to 16064.5) | 2099.3 (1172.8 to 3757.7) | 17874.8 (8298.9 to 38500.1) | 13086.9 (6317.8 to 27108.8) | 2497.6 (1493.9 to 4175.7) |
| Week 24 | 2770.0 (NA to NA) | 9446.6 (6001.8 to 14868.6) | 6424.4 (2758.4 to 14962.3) | 2381.2 (1081.9 to 5241.0) | 6235.7 (3717.7 to 10459.3) | 5275.9 (3016.0 to 9228.9) | 2128.9 (923.8 to 4906.4) |
| Week 26 | 3890.0 (NA to NA) | 13142.7 (8034.0 to 21499.9) | 8779.5 (4383.4 to 17584.7) | 2488.8 (1181.0 to 5244.9) | 32099.1 (10656.3 to 96688.8) | 17640.8 (12002.0 to 25928.7) | 2174.3 (918.7 to 5146.0) |
| Week 36 | 2709.4 (2188.5 to 3354.3) | 12713.9 (7440.1 to 21726.0) | 6886.6 (2758.6 to 17191.7) | 2358.4 (1297.9 to 4285.5) | 14491.7 (6314.7 to 33257.6) | 10543.9 (7864.9 to 14135.6) | 2273.8 (1091.3 to 4737.7) |
| Week 48 | 2287.7 (1733.1 to 3019.9) | 9108.4 (5469.1 to 15169.4) | 5886.6 (2446.7 to 14162.3) | 2254.2 (1218.0 to 4171.7) | 7237.2 (3437.4 to 15237.7) | 6321.2 (4670.3 to 8555.7) | 2213.5 (969.2 to 5055.1) |
| Week 50 | 7472.5 (3323.2 to 16802.6) | 13280.3 (7620.5 to 23143.7) | 8536.0 (4170.1 to 17472.6) | 2340.1 (1268.6 to 4317.0) | 30248.2 (12315.3 to 74294.5) | 25491.5 (10441.9 to 62231.3) | 2436.9 (1199.6 to 4950.6) |
| Week 67 | 3219.8 (2578.6 to 4020.4) | 8944.8 (5974.4 to 13392.0) | 6180.6 (2623.0 to 14563.1) | 2080.4 (1122.4 to 3856.0) | 13077.0 (7162.9 to 23874.1) | 10082.0 (4602.9 to 22083.5) | 2295.7 (1480.2 to 3560.6) |
| Week 74 | 2791.9 (2285.3 to 3410.8) | 8993.0 (5314.7 to 15216.9) | 5383.9 (2349.5 to 12337.4) | 2126.0 (1168.7 to 3867.5) | 10835.5 (5870.1 to 20000.8) | 6788.7 (3017.2 to 15274.3) | 2178.8 (1549.6 to 3063.5) |
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
| AU/mL | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Baseline | 374.7 (287.3 to 488.8) | 357.1 (238.3 to 535.2) | 355.4 (125.2 to 1008.8) | 251.7 (198.1 to 319.7) | 223.0 (135.4 to 367.5) | 394.1 (290.2 to 535.3) | 261.0 (144.2 to 472.4) |
| Week 2 | 2609.5 (1098.9 to 6196.6) | 8753.9 (3767.6 to 20339.8) | 6549.6 (1614.8 to 26564.8) | 230.4 (186.1 to 285.1) | 744.5 (390.0 to 1421.1) | 2657.0 (524.4 to 13461.1) | 233.7 (118.9 to 459.4) |
| Week 8 | 1065.0 (512.3 to 2213.9) | 3631.9 (1709.8 to 7714.8) | 2000.8 (704.1 to 5685.1) | 243.1 (192.6 to 306.7) | 2564.1 (1753.4 to 3749.5) | 4349.6 (1372.9 to 13780.8) | 253.3 (132.3 to 484.9) |
| Week 10 | 1508.6 (649.3 to 3505.4) | 4217.5 (2120.6 to 8387.6) | 2921.6 (1391.6 to 6133.8) | 242.5 (208.3 to 282.4) | 84688.8 (36848.8 to 194638.7) | 46411.7 (23609.7 to 91235.4) | 262.8 (106.9 to 646.4) |
| Week 24 | 578.0 (NA to NA) | 1124.8 (647.0 to 1955.5) | 851.6 (364.5 to 1989.6) | 343.3 (285.9 to 412.2) | 16444.7 (6570.8 to 41155.8) | 19762.7 (8882.8 to 43968.6) | 236.2 (130.0 to 429.2) |
| Week 26 | 798.0 (NA to NA) | 1375.2 (980.6 to 1928.6) | 1859.0 (867.8 to 3982.4) | 339.5 (262.9 to 438.2) | 162241.1 (72817.9 to 361479.1) | 74795.1 (40734.0 to 137337.3) | 237.9 (139.4 to 406.1) |
| Week 36 | 523.3 (358.4 to 764.1) | 828.6 (458.0 to 1499.1) | 806.3 (306.5 to 2121.3) | 240.6 (180.5 to 320.6) | 59209.8 (35862.2 to 97757.4) | 31504.2 (19187.4 to 51727.4) | 310.1 (170.6 to 563.7) |
| Week 48 | 416.0 (279.6 to 618.9) | 635.2 (354.9 to 1136.9) | 417.1 (212.1 to 820.1) | 243.1 (181.6 to 325.4) | 25681.2 (14983.1 to 44017.8) | 13486.3 (7865.4 to 23124.1) | 282.8 (153.1 to 522.4) |
| Week 50 | 1023.0 (594.5 to 1760.3) | 1092.4 (595.6 to 2003.5) | 1132.9 (472.2 to 2718.2) | 231.8 (172.2 to 312.0) | 197833.5 (123950.4 to 315756.0) | 70122.6 (32136.3 to 153009.8) | 286.5 (157.2 to 522.1) |
| Week 67 | 450.1 (342.4 to 591.7) | 551.2 (321.7 to 944.6) | 570.6 (329.0 to 989.6) | 269.6 (205.4 to 353.8) | 69607.0 (43695.0 to 110885.3) | 32158.7 (12000.4 to 86178.7) | 282.6 (213.5 to 374.0) |
| Week 74 | 439.4 (366.2 to 527.3) | 590.0 (327.6 to 1062.4) | 571.9 (334.2 to 978.6) | 253.3 (172.3 to 372.5) | 51718.4 (30576.2 to 87479.7) | 21920.5 (7062.2 to 68039.9) | 267.4 (156.3 to 457.3) |
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
| AU/mL | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Baseline | 355.3 (162.5 to 777.0) | 154.8 (113.9 to 210.4) | 368.6 (247.9 to 547.9) | 297.5 (166.8 to 530.6) | 337.3 (190.5 to 597.4) | 147.1 (50.2 to 431.4) | 248.5 (100.0 to 617.5) |
| Week 2 | 25951.9 (11858.8 to 56793.5) | 15563.7 (10500.7 to 23067.8) | 20464.3 (6475.2 to 64676.0) | 297.5 (167.9 to 527.4) | 494.9 (236.3 to 1036.2) | 327.4 (100.9 to 1062.4) | 237.2 (76.6 to 734.5) |
| Week 8 | 3666.8 (1795.4 to 7488.6) | 3439.4 (2477.0 to 4775.7) | 4936.6 (1625.2 to 14994.8) | 274.9 (158.5 to 476.8) | 476.8 (241.0 to 943.4) | 276.8 (108.5 to 706.1) | 217.4 (76.7 to 615.9) |
| Week 10 | 4436.9 (2723.2 to 7229.1) | 4792.5 (3376.5 to 6802.3) | 7672.5 (3433.5 to 17144.9) | 288.5 (165.5 to 503.0) | 564.7 (266.4 to 1197.1) | 349.6 (139.2 to 877.8) | 225.5 (74.3 to 684.3) |
| Week 24 | 696.0 (NA to NA) | 1967.4 (1598.0 to 2422.3) | 2758.4 (1380.1 to 5513.0) | 345.0 (158.5 to 750.9) | 473.9 (215.5 to 1042.1) | 202.6 (118.6 to 346.0) | 183.3 (66.6 to 504.3) |
| Week 26 | 2830.0 (NA to NA) | 5137.1 (3815.8 to 6916.0) | 7950.1 (3857.6 to 16384.4) | 334.8 (154.6 to 725.2) | 483.3 (213.7 to 1093.0) | 153.5 (69.1 to 341.1) | 181.8 (64.9 to 509.6) |
| Week 36 | 806.2 (394.4 to 1647.9) | 2958.8 (2148.6 to 4074.6) | 2906.2 (1516.6 to 5569.2) | 308.2 (168.4 to 564.0) | 356.1 (204.2 to 621.2) | 329.0 (143.4 to 754.5) | 265.4 (83.0 to 848.1) |
| Week 48 | 802.9 (383.6 to 1680.4) | 1789.3 (1318.7 to 2428.0) | 2362.7 (1131.0 to 4935.4) | 310.9 (173.0 to 558.5) | 368.6 (199.9 to 679.7) | 297.6 (91.5 to 967.3) | 278.1 (84.2 to 919.0) |
| Week 50 | 4714.6 (1996.9 to 11131.2) | 5214.3 (3348.3 to 8120.3) | 8509.3 (3839.7 to 18857.4) | 318.9 (174.9 to 581.1) | 360.5 (215.5 to 603.1) | 248.8 (92.0 to 672.8) | 275.0 (84.3 to 897.1) |
| Week 67 | 1858.5 (879.0 to 3929.7) | 1898.6 (1275.1 to 2827.0) | 4539.9 (2155.0 to 9564.3) | 431.9 (233.9 to 797.3) | 393.7 (199.1 to 778.7) | 240.5 (73.6 to 785.3) | 186.7 (57.9 to 602.1) |
| Week 74 | 1785.9 (801.8 to 3977.8) | 1509.7 (1063.2 to 2143.7) | 3880.2 (1741.4 to 8645.9) | 343.0 (191.9 to 613.3) | 449.9 (248.2 to 815.4) | 252.9 (75.6 to 845.9) | 348.0 (79.0 to 1533.3) |
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
| AU/mL | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Baseline | 153.0 (69.6 to 336.2) | 93.1 (66.8 to 129.6) | 124.4 (64.0 to 241.9) | 108.1 (73.4 to 159.2) | 93.7 (42.9 to 204.8) | 94.6 (36.6 to 244.7) | 119.3 (44.3 to 321.4) |
| Week 2 | 460.7 (185.3 to 1145.2) | 449.8 (222.5 to 909.6) | 737.8 (121.6 to 4478.3) | 105.4 (70.0 to 158.6) | 146.1 (56.5 to 378.0) | 139.6 (48.2 to 404.2) | 129.9 (43.7 to 386.3) |
| Week 8 | 228.3 (107.3 to 485.6) | 209.6 (127.3 to 345.0) | 333.4 (72.0 to 1543.1) | 98.2 (67.3 to 143.5) | 116.8 (53.7 to 253.8) | 101.3 (38.4 to 267.2) | 116.5 (44.1 to 307.8) |
| Week 10 | 220.8 (135.4 to 360.0) | 209.5 (133.8 to 328.0) | 409.5 (127.0 to 1320.6) | 101.3 (68.9 to 148.8) | 119.2 (54.3 to 261.3) | 123.2 (46.5 to 326.2) | 117.4 (43.6 to 316.0) |
| Week 24 | 231.0 (NA to NA) | 134.2 (98.3 to 183.0) | 181.2 (75.1 to 437.3) | 90.2 (63.3 to 128.5) | 100.8 (51.3 to 198.2) | 102.3 (46.0 to 227.6) | 104.1 (40.1 to 270.4) |
| Week 26 | 256.0 (NA to NA) | 198.8 (158.9 to 248.7) | 286.2 (136.2 to 601.6) | 87.2 (57.4 to 132.5) | 107.9 (53.3 to 218.8) | 105.9 (48.0 to 233.8) | 103.3 (40.8 to 261.4) |
| Week 36 | 95.2 (51.2 to 177.0) | 264.6 (198.1 to 353.3) | 476.7 (282.4 to 804.7) | 107.7 (61.5 to 188.7) | 101.1 (51.4 to 198.9) | 100.1 (37.2 to 268.9) | 147.4 (58.1 to 373.9) |
| Week 48 | 111.6 (43.0 to 289.6) | 232.9 (178.6 to 303.8) | 468.3 (191.5 to 1145.1) | 120.9 (70.7 to 206.9) | 125.8 (67.3 to 235.1) | 133.4 (45.6 to 390.7) | 162.6 (62.6 to 422.4) |
| Week 50 | 171.9 (74.8 to 395.0) | 349.2 (270.4 to 450.9) | 507.4 (227.5 to 1131.9) | 108.3 (61.3 to 191.2) | 102.4 (52.2 to 201.0) | 110.1 (44.3 to 274.1) | 164.9 (65.0 to 418.2) |
| Week 67 | 147.8 (61.5 to 355.0) | 202.7 (142.6 to 288.0) | 342.5 (116.4 to 1007.7) | 109.7 (70.9 to 169.6) | 93.1 (43.0 to 201.5) | 130.9 (49.2 to 348.2) | 144.9 (54.7 to 384.0) |
| Week 74 | 144.1 (43.4 to 478.7) | 169.1 (121.8 to 234.6) | 329.9 (111.9 to 972.3) | 128.2 (90.0 to 182.6) | 108.4 (51.4 to 228.6) | 130.6 (49.2 to 346.3) | 161.8 (58.5 to 447.2) |
CDR-SB means Clinical Dementia Rating - Sum of Boxes. The score ranges from 0 to 18. A higher score indicates a worse outcome.
Results for this outcome have not been posted.
RBANS means Repeatable Battery for the Assessment of Neuropsychological Status. The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.
Results for this outcome have not been posted.
NPI means Neuropsychiatric Inventory. The score ranges from 0 to 144. A higher score indicates a worse outcome.
Results for this outcome have not been posted.
Collected over The safety reporting period covering any Adverse Events which were treatment-emergent is the interval between the first dosing (Visit 1, Week 0) and the last safety follow-up visit (Visit 11, Week 74); up to 74 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sub-Cohort 1.1 (ACI-35.030 300 μg) | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Sub-Cohort 1.2 (ACI-35.030 900 μg) | 0/19 (0%) | 2/19 (10.5%) | 17/19 (89.5%) |
| Sub-Cohort 1.3 (ACI-35.030 1800 μg) | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Cohort 1 Placebo | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Sub-Cohort 2.1 (JACI-35.054 15 μg) | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Sub-Cohort 2.2 (JACI-35.054 60 μg) | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Cohort 2 Placebo | 0/4 (0%) | 1/4 (25%) | 4/4 (100%) |
| Event | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/6 | 0/19 | 0/6 | 0/10 | 0/6 | 0/6 | 1/4 |
| DiverticulitisInfections and infestations | 1/6 | 0/19 | 0/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Sinus node dysfunctionCardiac disorders | 1/6 | 0/19 | 0/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| DiverticulumGastrointestinal disorders | 0/6 | 0/19 | 1/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Aneurysm thrombosisVascular disorders | 0/6 | 0/19 | 1/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Peripheral artery aneurysmVascular disorders | 0/6 | 0/19 | 1/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Haemorrhagic fever with renal syndromeInfections and infestations | 0/6 | 1/19 | 0/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Injection site rashGeneral disorders | 0/6 | 1/19 | 0/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Post-traumatic painInjury, poisoning and procedural complications | 0/6 | 1/19 | 0/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| DizzinessNervous system disorders | 0/6 | 1/19 | 0/6 | 0/10 | 0/6 | 0/6 | 0/4 |
| Event | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo |
|---|---|---|---|---|---|---|---|
| Injection site reactionGeneral disorders | 2/6 | 14/19 | 6/6 | 0/10 | 1/6 | 2/6 | 0/4 |
| PyrexiaGeneral disorders | 1/6 | 3/19 | 1/6 | 0/10 | 3/6 | 0/6 | 0/4 |
| NasopharyngitisInfections and infestations | 3/6 | 2/19 | 1/6 | 1/10 | 0/6 | 1/6 | 1/4 |
| HeadacheNervous system disorders | 0/6 | 4/19 | 3/6 | 0/10 | 2/6 | 1/6 | 1/4 |
| COVID-19Infections and infestations | 0/6 | 7/19 | 2/6 | 3/10 | 1/6 | 0/6 | 1/4 |
| MalaiseGeneral disorders | 0/6 | 2/19 | 0/6 | 0/10 | 2/6 | 1/6 | 0/4 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/6 | 0/19 | 0/6 | 0/10 | 2/6 | 0/6 | 0/4 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/6 | 2/19 | 0/6 | 0/10 | 2/6 | 0/6 | 0/4 |
| Ventricular extrasystolesCardiac disorders | 0/6 | 0/19 | 0/6 | 0/10 | 2/6 | 0/6 | 0/4 |
| Urinary tract infectionInfections and infestations | 0/6 | 0/19 | 0/6 | 1/10 | 0/6 | 0/6 | 1/4 |
The data of the 57 subjects who have been randomized in the study (e.g. signed the consent, eligible and received at east 1 administration of the study drug) have been considered
| Age, Categorical(Participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 2 | 2 | 1 | 5 | 1 | 20 |
| >=65 years | 3 | 13 | 4 | 8 | 5 | 1 | 3 | 37 |
| Age, Continuous(years) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 65.5 ± 5.01 | 68.0 ± 6.29 | 64.7 ± 4.63 | 67.7 ± 4.60 | 66.7 ± 6.22 | 63.0 ± 4.77 | 68.0 ± 6.16 | 66.67 ± 5.54 |
| Sex: Female, Male(Participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 4 | 9 | 2 | 5 | 3 | 3 | 4 | 30 |
| Male | 2 | 10 | 4 | 5 | 3 | 3 | 0 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 18 | 6 | 10 | 6 | 6 | 4 | 56 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 6 | 19 | 6 | 10 | 6 | 6 | 4 | 57 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Netherlands | 0 | 6 | 2 | 2 | 3 | 1 | 0 | 14 |
| Sweden | 0 | 4 | 0 | 1 | 0 | 1 | 0 | 6 |
| Finland | 6 | 6 | 2 | 7 | 3 | 4 | 4 | 32 |
| United Kingdom | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 5 |
| Clinical Dementia Rating (CDR) - Global Score(Participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Score = 0.5 | 6 | 17 | 5 | 8 | 6 | 5 | 3 | 50 |
| Score = 1 | 0 | 2 | 1 | 2 | 0 | 1 | 1 | 7 |
| Concomitant Medication(Participants) | Sub-Cohort 1.1 (ACI-35.030 300 μg) | Sub-Cohort 1.2 (ACI-35.030 900 μg) | Sub-Cohort 1.3 (ACI-35.030 1800 μg) | Cohort 1 Placebo | Sub-Cohort 2.1 (JACI-35.054 15 μg) | Sub-Cohort 2.2 (JACI-35.054 60 μg) | Cohort 2 Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Acetylcholinesterase Inhibitors and/or Memantine | 5 | 14 | 5 | 8 | 3 | 5 | 4 | 44 |
| No Acetylcholinesterase Inhibitors or Memantine | 1 | 5 | 1 | 2 | 3 | 1 | 0 | 13 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) are not planned to be shared for this early-phase non-pivotal ACI-35-1802 Phase 1b/2a study. However, group-level data may be shared to qualified researchers who engage in rigorous independent scientific research after the review and approval of a proposal sent to the sponsor (see Contacts) and the execution of a data sharing agreement. In addition, the Clinical Study Protocol and the Statistical Plan will be available in this registry once the study results are released.
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