A Phase 1/2 interventional study of Active Treatment- CT1812 100 mg and Active Treatment- CT1812 300 mg in Alzheimer Disease, sponsored by Cognition Therapeutics. Completed at 1 site in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Cognition Therapeutics · Phase 1/2, Interventional, and Treatment
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Among 1,939 studies in Alzheimer Disease with a site in United States — 345 open to participants now, 445 under way, 40 of them phase 3. Alzheimer Disease · United States.
Among the 1,939 studies in Alzheimer Disease with a site in United States, this one is the 1,018th largest by enrollment of the 1,608 interventional ones that give a count, is one of 104 that started in 2018, is one of 67 in phase 1/2, and was the 939th registered.
3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →345 of the 1,939 studies in Alzheimer Disease with a site in United States are open now. Recruiting first, the newest first:
National Institute on Aging (NIA) · Sites in United States
Ages 55–110 · Healthy volunteers
National Institute on Aging (NIA) · Sites in United States
Ages 65–120 · Healthy volunteers
Prevention Research Consortium Corp. · Sites in United States
Ages 55+ · Healthy volunteers
Hoffmann-La Roche · Sites in United States, Australia, France
Ages 50–90
University of Wisconsin, Madison · Sites in United States
Ages 60+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,939 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 371 · Phase 2 469 · Phase 3 230 · Phase 4 60
First in 1981; this study’s year is marked. 104 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 43 is below the median of 70 across 3,021 interventional studies indexed under Alzheimer Disease.
Median enrollment 73 across the 1,608 interventional studies, 160 across the 309 observational. Of the 1,377 that completed or were terminated, 590 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
731 of 1,939 have an industry lead sponsor. The 10 most frequent:
Cognition Therapeutics is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Cognition Therapeutics has 9 studies filed under Alzheimer Disease — fewer than ten, so there is no comparison to draw.
164 of the studies in Alzheimer Disease with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06585787Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) | 2026-11-24 |
| NCT06126224Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyA Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | 2026-12-09 |
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT05980949Phase 3Karuna Therapeutics, Inc., a Bristol Myers Squibb companyOpen-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) | 2027-09-07 |
Add all 164 to your calendar (.ics) → With an account.
Among the 1,939 studies in Alzheimer Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Study to Evaluate the Safety and Tolerability of Oral CT1812 in Subjects with Mild to Moderate Alzheimer's Disease.
This is a single-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for up 180 days for the Primary study and another 180 days for the double-blind extension study.
Each participant and caregiver participated in a screening period of up to 60 days, followed by the primary double-blind treatment period of 24 weeks (169 days +/-2) followed by an optional double-blind extension treatment period of another 24 weeks (337 days +/-2).
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.
Participants may be included in the study only if they meet all of the following criteria:
Men, and women of non-, 50-85 years of age inclusively, with a diagnosis of mild to moderate Alzheimer's disease according to the 2011 NIA-AA criteria and at least a 6 month decline in cognitive function documented in the medical record.
Exclusion Criteria:
Participants will be excluded from the study if any of the following conditions apply:
MRI incompatible implants and other for MRI, such as pacemaker, artificial joints, non-removable body piercings, etc. Additionally, participants who meet the following imaging exclusion criteria will not be included in this study:
Clinical or laboratory findings consistent with:
, advanced or unstable disease that may interfere with outcome evaluations, such as:
Clinically significant abnormalities in screening laboratory tests, including:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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 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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
High Dose CT1812
Drug: Active Treatment- CT1812 300 mg
Low Dose CT1812
Drug: Active Treatment- CT1812 100 mg
Matching Placebo
Drug: Placebo
CT1812
CT1812
Matching Placebo
Number of TEAEs, Related TEAEs, SAEs, and Related SAEs
Number of subjects reported with AEs and the number of AEs reported following administration of the IP summarized by treatment and grouped according to system organ class and preferred term, using descriptive statistics. Summaries of AEs were also presented by severity and by relationship to investigational product. In these summaries, subjects were counted only once per MedDRA term, for the AE of highest severity or least favorable relationship. Summaries were also presented of SAEs and of AEs leading to study withdrawal.
Time frame: Up to 12 months
Change From Baseline in the Imaging of [11C] UCB-J PET Distribution Volume Ratio (DVR)
The Distribution Volume Ratio (DVR) was used to determine the correlations with the cognitive and functional endpoints. For 11C UCB J, the imaging outcome measure was DVR as produced by the Simplified Reference Tissue Model (SRTM2) using dynamic scan data from 0 to 60 min and the whole cerebellum as a reference region. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of disease.
Time frame: Day 169
Change From Baseline in the Imaging of [18F]FDG PET SUV Ratio (SUVR)
For 18F FDG, the primary imaging outcome measure was the SUVR from 60-90 min post injection using whole cerebellum as a reference region. For SUVR, a composite region was determined, including: prefrontal, lateral temporal, posterior cingulate/precuneus, anterior cingulate, lateral parietal, medial temporal, and lateral occipital regions. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of the disease.
Time frame: Day 169
Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)
A composite region of AD affected brain regions was determined, including prefrontal, lateral temporal, posterior cingulate/precuneus, anterior cingulate, lateral parietal, medial temporal, and lateral occipital regions. Baseline is defined as the last measurement taken before the first dose of study drug. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of disease.
Time frame: Day 169
Change From Baseline in the Imaging of Functional MRI - Intrinsic Connectivity Contrast (ICC)
For resting state functional MRI, the outcome was ICC. With this approach a map of the total connectivity of each voxel to all other voxels was computed. For ICC, a composite region of AD affected brain regions was determined, including prefrontal, lateral temporal, posterior cingulate/precuneus, anterior cingulate, lateral parietal, medial temporal, and lateral occipital regions. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of disease.
Time frame: Day 169
Change From Baseline in the Cerebrospinal Fluid (CSF) Biomarkers
Change from baseline in CSF Aβ 40, CSF Aβ 42, CSF tau, CSF phospho-tau, CSF neurogranin (NRGN), CSF synaptotagmin, CSF(SNAP25), and CSF neurofilament light (NFL). Change from baseline is calculated as the observed value minus the baseline value.
Time frame: Day 169
Change From Baseline ADAS-Cog11 (Alzheimer's Disease Assessment Scale - Cognition Subscale)
The ADAS-Cog11 total score = the sum of all 11 individual items (word recall \[10\]; commands \[5\]; constructional praxis \[5\]; naming objects and fingers \[5\]; ideational praxis \[5\]; orientation \[8\]; word recognition \[12\]; remembering test instructions \[5\]; spoken language \[5\]; word finding \[5\]; and comprehension of spoken language \[5\]). The score range for ADAS-cog 11 is 0-70 where a higher score is worse performance. The ADAS-cog methodology is to sum scores for subscales. The results were calculated using the average change from baseline. Baseline is defined as the last measurement taken before the first dose of study drug is administered. Change is calculated as the observed value minus the baseline value. A negative change from baseline indicates improvement.
Time frame: Day 169
Change From Baseline ADAS-Cog13 (Alzheimer's Disease Assessment Scale - Cognition Subscale)
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 and the delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall \[DWR\] score is 0-10 and for Number Cancellation \[NC\] is 0-5, thus the score is ADAS-cog 11\[0-70\] plus the scores for DWR and NC). A higher score indicates worse performance. The ADAS-cog methodology is to sum scores for subscales. The results were calculated using the average change from baseline. Baseline is defined as the last measurement taken before the first dose of study drug. Change is calculated as the observed value minus the baseline value. A negative change from baseline indicates improvement in cognitive function.
Time frame: Day 169
Change From Baseline ADAS-Cog14 (Alzheimer's Disease Assessment Scale - Cognition Subscale)
The ADAS-Cog14 total score includes all of the items in the ADAS-Cog13 \[0-85\] and the maze item which has a score range of 0-5. Thus, the total score for the ADAS-cog 14 is 0-90 where again a higher score is worst performance. The ADAS-cog methodology is to sum scores for subscales. The results were calculated using the average change from baseline. Baseline is defined as the last measurement taken before the first dose of study drug is administered. Change is calculated as the observed value minus the baseline value. A negative change from baseline indicates improvement in cognitive function.
Time frame: Day 169
Change From Baseline in ADCS-Activities of Daily Living (ADCS-ADL)
The ADCS-ADL is a 23-item informant-administered assessment of functional impairment in terms of activities of daily living. Informants respond to 23 questions about the subject's involvement and level of performance across items representing daily living. The questions range from basic to instrumental activities of daily living. Each item is rated from the highest level of independent performance to complete loss. The total score range is from 0-78 with lower scores indicating greater functional impairment. A positive change from baseline indicates improvement in function. The results were calculated using the average change from baseline. Higher scores mean better outcome. Negative mean indicates worsening of function. Positive mean indicates improvement of function.
Time frame: Day 169
Change From Baseline in Mini Mental State Exam (MMSE)
The MMSE assesses several aspects of memory and cognitive functioning including orientation, attention, concentration, comprehension, recall, and praxis. The total possible score is 30, with high scores indicating less impairment. Change from baseline is calculated as the observed value minus the baseline value. A positive change from baseline indicates improvement in cognition.
Time frame: Day 169
Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Scores were on a scale of 0 through 3, with 0=no dementia, 0.5=questionable dementia, 1=mild dementia, 2=moderate dementia, and 3=severe dementia. Cognitive and functional abilities that were assessed include Memory; Orientation; Judgment and Problem Solving; Community Affairs; Home and Hobbies; and Personal Care. Memory was considered as the primary driver for scoring and the other categories were secondary. The change from baseline in the CDR-SB total score was analyzed using the mixed model for repeated measures (MMRM). Change from baseline is calculated as the observed value minus the baseline value. Higher scores mean worsening of disease.
Time frame: Day 169
Change From Baseline in Alzheimer's Disease Clinical Study - Clinician Global Impression of Change (ADCS-CGIC)
The scale consists of a format with which a clinician may address clinically relevant overall change, including 15 areas under the domains of cognition, behavior, and social and daily functioning. For ADCS-CGIC, the individual data listing presented the original score on the seven-point scale. In addition, the seven-point score was collapsed to 3 groups, combining scores 1-3 to "Improved", 4 to "No change", and 5-7 to "Worsening". Lower scores indicate improvement.
Time frame: Day 169
Change From Baseline in the Cognitive Composite
The Cognitive composite included: 1. 6 ADAS-Cog items: word recall, orientation, delayed word recall, word recognition, number cancellation, and maze 2. 4 Neuropsychological Test Battery (NTB) items: Trail Making Test (TMT) A, Trail Making Test (TMT) B, Category Fluency Test (CFT), Digit span. Each individual z-score was calculated by first computing the baseline mean and standard deviation at baseline for all subjects within each individual component. The z-scores were then derived for each subject and timepoint by subtracting the corresponding baseline mean from the observed value and then dividing by the standard deviation at baseline. The sign of the z-score for the following components was reversed when deriving the Composite scores: Word recall, Orientation, Delayed Word Recall, Word Recognition, Maze, TMT A, TMT B. Z-score = 0 represents the population at baseline Positive Z-score = indicates improvement Negative Z-score= indicates worsening
Time frame: Day169
Change From Baseline in the Memory Composite
The memory composite includes 4 ADAS-COG (Alzheimer's Disease Assessment Scale - cognition subscale) items: word recall, orientation, delayed word recall, word recognition. The Memory composite score will be a composite z-score average similar to the Cognitive Composite score but will only be derived using the average of the ADAS-Cog Word Recall, Orientation, Delayed Word Recall, and Word Recognition items. If a subject is missing any of the four items at a timepoint, this composite score will not be derived. The score was calculated using z-scores of the items cited above where: Z-score = 0 represents the population at baseline. Positive Z-score = indicates improvement Negative Z-score= indicates worsening
Time frame: Day169
Change From Baseline in Attention Composite
The Attention composite score included: 1. 1 ADAS-COG (Alzheimer's Disease Assessment Scale -cognition subscale) item: Number Cancellation 2. 1 NTB item: Trail Making Test (TMT) A The Attention composite score will be a composite z-score average derived using the average of the Number Cancellation, Maze item from ADAS-Cog 14, and TMT A items. If a subject missed either of the three items at a timepoint, this composite score was derived. The score was calculated using z-scores of the items cited above where: Z-score = 0 represents the population at baseline. Positive Z-score = indicates improvement Negative Z-score= indicates worsening
Time frame: Day 169
Change From Baseline in the Executive Composite
The Executive composite included 1. 0 ADAS-COG (Alzheimer's Disease Assessment Scale - cognition subscale) items 2. 3 NTB (Neuropsychological Test Battery) items: CFT (Category Fluency Test), Digit Span, and Trail Making Test (TMT) B The Executive function composite score will be a composite z-score average derived using the average of the CFT Category Fluency Test), Digit Span, and TMT B items. If a subject is missing any of the three items at a timepoint, this composite score will not be derived. The score was calculated using z-scores of the items cited above where: Z-score = 0 represents the population at baseline. Positive Z-score = indicates improvement Negative Z-score= indicates worsening
Time frame: Day 169
Location Type: Medical Clinic
| Milestone | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Started | 8 | 8 | 7 |
| Completed | 5 | 6 | 6 |
| Not completed | 3 | 2 | 1 |
| Withdrew: Adverse event | 2 | 2 | 1 |
| Withdrew: Subject moved | 1 | 0 | 0 |
| Milestone | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Started | 3 | 6 | 4 |
| Completed | 3 | 6 | 4 |
| Not completed | 0 | 0 | 0 |
Number of subjects reported with AEs and the number of AEs reported following administration of the IP summarized by treatment and grouped according to system organ class and preferred term, using descriptive statistics. Summaries of AEs were also presented by severity and by relationship to investigational product. In these summaries, subjects were counted only once per MedDRA term, for the AE of highest severity or least favorable relationship. Summaries were also presented of SAEs and of AEs leading to study withdrawal.
| Participants | 300 mg | 100 mg | Placebo | All Subjects |
|---|---|---|---|---|
| All TEAEs | 7 | 8 | 6 | 21 |
| Mild TEAEs | 6 | 4 | 4 | 14 |
| Moderate TEAEs | 1 | 2 | 1 | 4 |
| Severe TEAEs | 0 | 2 | 1 | 3 |
| Related TEAEs | 4 | 3 | 4 | 11 |
| TEAEs Leading to Treatment Discontinuation | 2 | 2 | 1 | 5 |
| SAEs | 0 | 3 | 1 | 4 |
| Related SAEs | 0 | 0 | 0 | 0 |
The Distribution Volume Ratio (DVR) was used to determine the correlations with the cognitive and functional endpoints. For 11C UCB J, the imaging outcome measure was DVR as produced by the Simplified Reference Tissue Model (SRTM2) using dynamic scan data from 0 to 60 min and the whole cerebellum as a reference region. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of disease.
| ratio | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Imaging of [11C] UCB-J PET Distribution Volume Ratio (DVR) | -0.043 ± 0.020 | -0.019 ± 0.020 | 0.000 ± 0.020 |
For 18F FDG, the primary imaging outcome measure was the SUVR from 60-90 min post injection using whole cerebellum as a reference region. For SUVR, a composite region was determined, including: prefrontal, lateral temporal, posterior cingulate/precuneus, anterior cingulate, lateral parietal, medial temporal, and lateral occipital regions. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of the disease.
| ratio | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Imaging of [18F]FDG PET SUV Ratio (SUVR) | -0.084 ± 0.017 | -0.044 ± 0.017 | -0.053 ± 0.017 |
A composite region of AD affected brain regions was determined, including prefrontal, lateral temporal, posterior cingulate/precuneus, anterior cingulate, lateral parietal, medial temporal, and lateral occipital regions. Baseline is defined as the last measurement taken before the first dose of study drug. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of disease.
| cm^3 | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI) | -6.34 ± 3.49 | -5.59 ± 3.51 | -13.85 ± 3.39 |
For resting state functional MRI, the outcome was ICC. With this approach a map of the total connectivity of each voxel to all other voxels was computed. For ICC, a composite region of AD affected brain regions was determined, including prefrontal, lateral temporal, posterior cingulate/precuneus, anterior cingulate, lateral parietal, medial temporal, and lateral occipital regions. Change from baseline is calculated as the observed value minus the baseline value. A negative change from baseline indicates the progression of disease.
| ratio | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Imaging of Functional MRI - Intrinsic Connectivity Contrast (ICC) | 0.005 ± 0.006 | -0.008 ± 0.006 | -0.006 ± 0.007 |
Change from baseline in CSF Aβ 40, CSF Aβ 42, CSF tau, CSF phospho-tau, CSF neurogranin (NRGN), CSF synaptotagmin, CSF(SNAP25), and CSF neurofilament light (NFL). Change from baseline is calculated as the observed value minus the baseline value.
| pg/ml | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Aβ 40 (pg/ml) | -594.0 ± 381.57 | 517.70 ± 445.24 | 222.25 ± 397.27 |
| Aβ 42 (pg/ml) | -32.96 ± 17.55 | 11.62 ± 21.88 | -13.90 ± 19.66 |
| Tau (pg/ml) | -84.08 ± 111.96 | 121.22 ± 131.96 | 36.74 ± 120.70 |
| Phospho-tau (pg/ml) | -7.71 ± 12.60 | 5.80 ± 14.91 | -4.67 ± 13.59 |
| NRGN (pg/ml) | -26.79 ± 16.50 | 14.96 ± 19.61 | -5.54 ± 17.77 |
| Synaptotagmin (pg/ml) | 0.88 ± 2.24 | 6.37 ± 2.64 | 0.68 ± 2.44 |
| SNAP-25 (pg/ml) | -3.15 ± 1.54 | 0.74 ± 1.83 | 1.36 ± 1.66 |
| NFL (pg/ml) | 210.77 ± 149.24 | 265.74 ± 176.40 | -24.02 ± 164.56 |
The ADAS-Cog11 total score = the sum of all 11 individual items (word recall \[10\]; commands \[5\]; constructional praxis \[5\]; naming objects and fingers \[5\]; ideational praxis \[5\]; orientation \[8\]; word recognition \[12\]; remembering test instructions \[5\]; spoken language \[5\]; word finding \[5\]; and comprehension of spoken language \[5\]). The score range for ADAS-cog 11 is 0-70 where a higher score is worse performance. The ADAS-cog methodology is to sum scores for subscales. The results were calculated using the average change from baseline. Baseline is defined as the last measurement taken before the first dose of study drug is administered. Change is calculated as the observed value minus the baseline value. A negative change from baseline indicates improvement.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline ADAS-Cog11 (Alzheimer's Disease Assessment Scale - Cognition Subscale) | 1.78 ± 2.101 | 1.28 ± 2.091 | 1.37 ± 2.144 |
The ADAS-Cog13 total score includes all of the items in the ADAS-Cog11 and the delayed word recall and the number cancellation. For the ADAS-cog 13 the range is 0-85 (score range for Delayed Word Recall \[DWR\] score is 0-10 and for Number Cancellation \[NC\] is 0-5, thus the score is ADAS-cog 11\[0-70\] plus the scores for DWR and NC). A higher score indicates worse performance. The ADAS-cog methodology is to sum scores for subscales. The results were calculated using the average change from baseline. Baseline is defined as the last measurement taken before the first dose of study drug. Change is calculated as the observed value minus the baseline value. A negative change from baseline indicates improvement in cognitive function.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline ADAS-Cog13 (Alzheimer's Disease Assessment Scale - Cognition Subscale) | 2.62 ± 2.157 | 1.73 ± 2.146 | 1.02 ± 2.178 |
The ADAS-Cog14 total score includes all of the items in the ADAS-Cog13 \[0-85\] and the maze item which has a score range of 0-5. Thus, the total score for the ADAS-cog 14 is 0-90 where again a higher score is worst performance. The ADAS-cog methodology is to sum scores for subscales. The results were calculated using the average change from baseline. Baseline is defined as the last measurement taken before the first dose of study drug is administered. Change is calculated as the observed value minus the baseline value. A negative change from baseline indicates improvement in cognitive function.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline ADAS-Cog14 (Alzheimer's Disease Assessment Scale - Cognition Subscale) | 1.25 ± 2.544 | 1.42 ± 2.245 | 1.65 ± 2.290 |
The ADCS-ADL is a 23-item informant-administered assessment of functional impairment in terms of activities of daily living. Informants respond to 23 questions about the subject's involvement and level of performance across items representing daily living. The questions range from basic to instrumental activities of daily living. Each item is rated from the highest level of independent performance to complete loss. The total score range is from 0-78 with lower scores indicating greater functional impairment. A positive change from baseline indicates improvement in function. The results were calculated using the average change from baseline. Higher scores mean better outcome. Negative mean indicates worsening of function. Positive mean indicates improvement of function.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in ADCS-Activities of Daily Living (ADCS-ADL) | -3.16 ± 1.646 | -0.31 ± 1.522 | 2.21 ± 1.641 |
The MMSE assesses several aspects of memory and cognitive functioning including orientation, attention, concentration, comprehension, recall, and praxis. The total possible score is 30, with high scores indicating less impairment. Change from baseline is calculated as the observed value minus the baseline value. A positive change from baseline indicates improvement in cognition.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Mini Mental State Exam (MMSE) | -2.92 ± 1.540 | -1.26 ± 1.448 | -0.74 ± 1.547 |
Scores were on a scale of 0 through 3, with 0=no dementia, 0.5=questionable dementia, 1=mild dementia, 2=moderate dementia, and 3=severe dementia. Cognitive and functional abilities that were assessed include Memory; Orientation; Judgment and Problem Solving; Community Affairs; Home and Hobbies; and Personal Care. Memory was considered as the primary driver for scoring and the other categories were secondary. The change from baseline in the CDR-SB total score was analyzed using the mixed model for repeated measures (MMRM). Change from baseline is calculated as the observed value minus the baseline value. Higher scores mean worsening of disease.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) | 0.72 ± 0.421 | 0.39 ± 0.399 | 0.17 ± 0.409 |
The scale consists of a format with which a clinician may address clinically relevant overall change, including 15 areas under the domains of cognition, behavior, and social and daily functioning. For ADCS-CGIC, the individual data listing presented the original score on the seven-point scale. In addition, the seven-point score was collapsed to 3 groups, combining scores 1-3 to "Improved", 4 to "No change", and 5-7 to "Worsening". Lower scores indicate improvement.
| score on a scale | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Alzheimer's Disease Clinical Study - Clinician Global Impression of Change (ADCS-CGIC) | 4.80 ± 0.279 | 4.50 ± 0.257 | 4.68 ± 0.257 |
The Cognitive composite included: 1. 6 ADAS-Cog items: word recall, orientation, delayed word recall, word recognition, number cancellation, and maze 2. 4 Neuropsychological Test Battery (NTB) items: Trail Making Test (TMT) A, Trail Making Test (TMT) B, Category Fluency Test (CFT), Digit span. Each individual z-score was calculated by first computing the baseline mean and standard deviation at baseline for all subjects within each individual component. The z-scores were then derived for each subject and timepoint by subtracting the corresponding baseline mean from the observed value and then dividing by the standard deviation at baseline. The sign of the z-score for the following components was reversed when deriving the Composite scores: Word recall, Orientation, Delayed Word Recall, Word Recognition, Maze, TMT A, TMT B. Z-score = 0 represents the population at baseline Positive Z-score = indicates improvement Negative Z-score= indicates worsening
| Z-Score | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Cognitive Composite | -0.33 ± 0.109 | -0.11 ± 0.102 | -0.10 ± 0.109 |
The memory composite includes 4 ADAS-COG (Alzheimer's Disease Assessment Scale - cognition subscale) items: word recall, orientation, delayed word recall, word recognition. The Memory composite score will be a composite z-score average similar to the Cognitive Composite score but will only be derived using the average of the ADAS-Cog Word Recall, Orientation, Delayed Word Recall, and Word Recognition items. If a subject is missing any of the four items at a timepoint, this composite score will not be derived. The score was calculated using z-scores of the items cited above where: Z-score = 0 represents the population at baseline. Positive Z-score = indicates improvement Negative Z-score= indicates worsening
| Z-score | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Memory Composite | -0.49 ± 0.201 | -0.18 ± 0.201 | -0.14 ± 0.198 |
The Attention composite score included: 1. 1 ADAS-COG (Alzheimer's Disease Assessment Scale -cognition subscale) item: Number Cancellation 2. 1 NTB item: Trail Making Test (TMT) A The Attention composite score will be a composite z-score average derived using the average of the Number Cancellation, Maze item from ADAS-Cog 14, and TMT A items. If a subject missed either of the three items at a timepoint, this composite score was derived. The score was calculated using z-scores of the items cited above where: Z-score = 0 represents the population at baseline. Positive Z-score = indicates improvement Negative Z-score= indicates worsening
| Z-score | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Attention Composite | -0.01 ± 0.158 | 0.15 ± 0.132 | -0.13 ± 0.139 |
The Executive composite included 1. 0 ADAS-COG (Alzheimer's Disease Assessment Scale - cognition subscale) items 2. 3 NTB (Neuropsychological Test Battery) items: CFT (Category Fluency Test), Digit Span, and Trail Making Test (TMT) B The Executive function composite score will be a composite z-score average derived using the average of the CFT Category Fluency Test), Digit Span, and TMT B items. If a subject is missing any of the three items at a timepoint, this composite score will not be derived. The score was calculated using z-scores of the items cited above where: Z-score = 0 represents the population at baseline. Positive Z-score = indicates improvement Negative Z-score= indicates worsening
| Z-score | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| Change From Baseline in the Executive Composite | -0.35 ± 0.366 | 0.66 ± 0.364 | -0.03 ± 0.256 |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 300 mg | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| 100 mg | 0/8 (0%) | 3/8 (37.5%) | 8/8 (100%) |
| Placebo | 0/7 (0%) | 1/7 (14.3%) | 6/7 (85.7%) |
| Event | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| EncephalitisInfections and infestations | 0/8 | 0/8 | 1/7 |
| UreterolithiasisRenal and urinary disorders | 0/8 | 1/8 | 0/7 |
| Thalamic InfarctionNervous system disorders | 0/8 | 1/8 | 0/7 |
| Psychotic disorderPsychiatric disorders | 0/8 | 1/8 | 0/7 |
| SeizureNervous system disorders | 0/8 | 1/8 | 0/7 |
| Event | 300 mg | 100 mg | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 3/8 | 2/8 | 2/7 |
| Upper respiratory tract infectionInfections and infestations | 0/8 | 2/8 | 0/7 |
| Urinary tract infectionInfections and infestations | 0/8 | 2/8 | 0/7 |
| VomitingGastrointestinal disorders | 0/8 | 2/8 | 1/7 |
| Liver function test increasedInvestigations | 2/8 | 0/8 | 0/7 |
| EncephalitisInfections and infestations | 0/8 | 0/8 | 1/7 |
| Cerebral microhaemorrhageNervous system disorders | 0/8 | 0/8 | 1/7 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 0/8 | 1/7 |
| Swelling faceSkin and subcutaneous tissue disorders | 0/8 | 0/8 | 1/7 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/8 | 0/8 | 1/7 |
| Age, Continuous(years) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 69.6 ± 10.9 | 68.0 ± 9.3 | 72.6 ± 5.8 | 70.0 ± 8.8 |
| Sex: Female, Male(Participants) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 4 | 4 | 3 | 11 |
| Male | 4 | 4 | 4 | 12 |
| Ethnicity (NIH/OMB)(Participants) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 8 | 7 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 1 | 1 |
| White | 8 | 8 | 6 | 22 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Weight(kg) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 76.2 ± 16.9 | 85.6 ± 5.0 | 74.8 ± 9.2 | 79.0 ± 12.1 |
| Height(cm) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 170.3 ± 9.9 | 171.4 ± 12.5 | 172.1 ± 12.1 | 171.2 ± 11.0 |
| Body Mass Index (BMI)(kg/m^2) | 300 mg | 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 26.3 ± 5.7 | 29.5 ± 4.1 | 25.2 ± 1.8 | 27.1 ± 4.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Oct 2020, 30 months.
Results were first posted in Mar 2023, 2 years 4 months after primary completion.
Of 62 phase 1/2 interventional studies under Alzheimer Disease, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's 30 months is below that.
How these figures are worked out, and which studies are left out of them.
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Cognition Therapeutics