A Phase 1/2 interventional study of Placebo (Study Part 1a) and ACI-24.060 at Dose A in Study Part 1a in Amyloid Plaque, Beta-Amyloid and DSAD, sponsored by AC Immune SA. Recruiting at 26 sites in 3 countries. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by AC Immune SA · Phase 1/2, Interventional, and Treatment
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.
This phase 1b/2 study will be in 2 parts. Study Part 1 will involve subjects with prodromal Alzheimer's disease and is divided into Part 1a and Part 1b. Study Part 2 will involve subjects with Down syndrome.
34 studies on the registry are indexed under Plaque, Amyloid; 10 are open to participants now.
This study's planned enrollment of 304 is above the median of 54 across 28 interventional studies indexed under Plaque, Amyloid.
Browse Plaque, Amyloid 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.
Study Part 1a and Part 1b
Study Part 2
Exclusion Criteria:
Current use of or immunomodulating drugs or their use within the 6 months before study screening. Current use of oral or their use within the 3 months before study screening.
Additional Exclusion Criteria in Study Part 2
The following are exclusion criteria at the time of randomization but will not be considered as exclusionary after treatment assignment:
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.
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.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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 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.
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.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
Prodromal AD participants receive placebo at predefined time points over 48 weeks
Biological: Placebo (Study Part 1a)
Prodromal AD participants receive dose A of ACI-24.060 at predefined time points over 48 weeks
Biological: ACI-24.060 at Dose A in Study Part 1a
Prodromal AD participants receive dose B of ACI-24.060 at predefined time points over 48 weeks.
Biological: ACI-24.060 at Dose B in Study Part 1a
Prodromal AD participants receive dose C of ACI-24.060 at predefined time points over 48 weeks.
Biological: ACI-24.060 at Dose C in Study Part 1a
Prodromal AD participants receive ACI-24.060 with an additional adjuvant at Dose D at predefined time points over 74 weeks.
Biological: ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
Participants with Down syndrome receive placebo at predefined time points over 74 weeks
Biological: Placebo (Study Part 2)
Participants with Down syndrome receive dose A of ACI-24.060 at predefined time points over 74 weeks. Dose A will be a dose already tested in Study Part 1.
Biological: ACI-24.060 at Dose A in Study Part 2
Participants with Down syndrome may optionally receive a dose B of ACI-24.060 at predefined time points over 74 weeks.
Biological: ACI-24.060 at Dose B in Study Part 2
Participants with Down syndrome receive dose C of ACI-24.060 at predefined time points over 74 weeks. Dose C will be a dose already tested in Study Part 1.
Biological: ACI-24.060 at Dose C in Study Part 2
Prodromal AD participants receive ACI-24.060 with an additional adjuvant at Dose E at predefined time points over 74 weeks.
Biological: ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b
Prodromal AD participants receive placebo at predefined time points over 74 weeks
Biological: Placebo (Study Part 1b)
Administration of Placebo in Study Part 1a
Administration of Dose A of ACI-24.060 in Study Part 1a
Administration of Dose B of ACI-24.060 in Study Part 1a
Administration of Dose C of ACI-24.060 in Study Part 1a
Administration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
Administration of Placebo in Study Part 2
Administration of Dose A of ACI-24.060 in Study Part 2. Dose A will be a dose already tested in Study Part 1a
Administration of Dose B of ACI-24.060 in Study Part 2
Administration of Dose C of ACI-24.060 in Study Part 2
Administration of Placebo in Study Part 1b
Administration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Time frame: From Screening to Week 74 (Study Part 1a) and from Screening to Week 100 (Study Part 1b)
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Time frame: From Screening to Week 100 (Study Part 2)
Number of participants with abnormal MRI results
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Number of participants with abnormal MRI results
Time frame: From Baseline to Week 100 (Study Part 2)
Number of participants with abnormal physical and neurological examination results
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Number of participants with abnormal physical and neurological examination results
Time frame: From Baseline to Week 100 (Study Part 2)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline to Week 100 (Study Part 2)
Change from baseline in Anti-Abeta antibody titers in blood
Time frame: From Baseline to Week 100 (Study Part 2)
Change from baseline in Anti-Abeta antibody titers
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline on brain amyloid levels
Brain amyloid load measured via PET imaging. An increase indicates a worsening.
Time frame: From Baseline to W100 (Study Part 2)
Change from baseline on brain amyloid levels
Brain amyloid load measured via PET imaging. An increase indicates a worsening.
Time frame: From Baseline to W48 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline on tau levels
Brain tau load measured via PET imaging. An increase indicates a worsening.
Time frame: From Baseline to W48 (Study Part 1a) and to W100 (Study Part 2)
Change from baseline in cognitive tests - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The total scale index score ranges from 40 to 160. A higher score indicates a better outcome.
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline in cognitive tests - Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 item (ADAS-Cog 13)
The score ranges from 0 to 85. A higher score indicates a worse outcome.
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline in clinical function tests - Clinical Dementia Rating Scale (CDR)
The score ranges from 0 to 18. A higher score indicates a worse outcome.
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline in cognitive tests - Modified Cued Recall Test (mCRT)
The modified CRT assesses verbal learning and episodic memory. The score ranges from X to Y. A higher score indicates a better outcome.
Time frame: From Baseline to Week 100 (Study Part 2)
Change from baseline in cognitive tests - Cambridge Cognitive Examination for Individuals with Down Syndrome (CAMCOG-DS2)
CAMCOG-DS measures cognitive decline. The total score ranges from 0 to 107. A higher score indicates a better outcome.
Time frame: From Baseline to Week 100 (Study Part 2)
Change from baseline in cognitive tests - Cambridge Neuropsychological Test Automated Battery-Paired Associates Learning (CANTAB-PAL)
The CANTAB-PAL assesses visual memory and new learning. A higher score indicates a better outcome.
Time frame: From Baseline to Week 100 (Study Part 2)
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Plan to share: Undecided
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Started Jun 2022 (actual). Primary completion is estimated for Apr 2029, 82 months after the start.
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AC Immune SA