AzTrials
AzTrials

Early Alzheimer's DiseasePhase 2NCT05531656

A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease

A Phase 2 study testing CT1812 in people with Early Alzheimer's Disease, run by Cognition Therapeutics at 50 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Early Alzheimer's Disease
What is being tested?
CT1812
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
540 participants
Where
50 sitesUnited States
Study dates
28 Jun 2023to 31 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 50-85 years.
  • Diagnosis of either MCI due to AD or mild AD dementia.
  • MMSE 20-30 (inclusive).
  • Amyloid PET scan of the brain or CSF biomarkers consistent with AD.
  • Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosis of Alzheimer's disease, as based on central read.

Who cannot join

  • Screening MRI of the brain indicative of significant abnormality.
  • Clinically significant abnormalities in screening laboratory tests.
  • Clinical or laboratory findings consistent with:
  • Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
  • Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
  • Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
  • A participant known to be actively infected with hepatitis B or hepatitis C at screening. History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C [HCV] antibody). Participants who have evidence of resolved hepatitis infection (e.g., HCV RNA negative) may be considered following discussion with the Medical Monitor.
  • A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, or bipolar disorder.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48109

  • John Hopkins University

    Baltimore, Maryland, 21224

  • Case Western Reserve University / University Hospitals

    Beachwood, Ohio, 44122

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Ralph H. Johnson VA MC

    Charleston, South Carolina, 29401

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of California

    Irvine, California, 92697

  • Mayo Clinic,Jacksonville

    Jacksonville, Florida, 32216

  • JEM Research Institute

    Lake Worth, Florida, 33462

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Sanders-Brown Center on Aging

    Lexington, Kentucky, 40504

  • University of Wisconsin

    Madison, Wisconsin, 53726

  • K2 Medical Research, LLC

    Maitland, Florida, 32751

  • Advanced Clinical Research Network, Corp

    Miami, Florida, 33135

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee, 37212

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06510

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Charter Research

    Orlando, Florida, 32803

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • Highlands Research Eastern MA

    Plymouth, Massachusetts, 02360

  • Summit Headlands LLC

    Portland, Oregon, 97210

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55901

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • University of Texas Health Science Center

    San Antonio, Texas, 78229

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Brain Matters Research Stuart

    Stuart, Florida, 34997

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • University of South Florida

    Tampa, Florida, 33613

  • Central States Research, LLC

    Tulsa, Oklahoma, 74136

  • Georgetown University

    Washington D.C., District of Columbia, 20057

  • Howard University

    Washington D.C., District of Columbia, 20060

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Conquest Research, LLC

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: Synaptic Therapy Alzheimer's Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease Over 18 Months.

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease.

Read the detailed description

This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo for approximately 18 months (72 weeks) in approximately 540 participants diagnosed with early Alzheimer's disease

Participants will be randomized 1:1:1 to receive either 100mg or 200mg of CT1812 or placebo. CT1812 or placebo will be administered as 2 capsules to be taken orally once daily.

Being tested
CT1812, Placebo
Keywords
Alzheimer's Disease
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT1812Drug

    Also called Study Drug Active

    Study Drug

  • PlaceboDrug

    Also called Matching Placebo

    Non-active study drug

Study groups in NCT05531656
Study groupRoleWhat they receive
CT1812 100 mgActive comparatorCT1812 at a dose of 100 n=180 group
Receives: Drug: CT1812
CT1812 200 mgActive comparatorCT1812 at a dose of 300mg, n=180 group
Receives: Drug: CT1812
PlaceboPlacebo comparatorPlacebo, n=180 group
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale.

    The Clinical Dementia Rating (CDR) is a clinical scale that describes 5 levels of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia as absent, questionable, mild, moderate, or severe (global CDR scores of 0, 0.5, 1, 2, or 3, respectively). The score is based on interviews with the participant and study partner, using a structured interview. A sum of boxes score (CDR-SB) provides an additional measure of change where each category has a maximum possible score of 3 points and the total score is a sum of the category scores giving a total possible score of 0 to 18 with higher scores indicating more impairment.

    Measured: 18 months

Secondary outcomes (5)

  1. Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13)

    Change from baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog 13) at 18 months.

    Measured: 18 months

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI.

    Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS - ADL) in people with Mild Cognitive Impairment (MCI) - ADCS-ADL-MCI at 18 months.

    Measured: 18 months

  3. Cerebrospinal fluid (CSF) concentrations of beta-amyloid (Aβ) 40 and 42, tau, phospho-tau (ptau), neurofilament light (NfL), neurogranin, and synaptotagmin.

    Change from baseline at 18 months.

    Measured: 18 months

  4. Plasma measures of Aβ fragments, ptau, and Neurofilament light (NfL)

    Change from baseline at 18 months.

    Measured: 18 months

  5. Volumetric Magnetic Resonance Imaging (MRI) including hippocampal and whole brain volume change

    Change from baseline at 18 months.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start28 Jun 2023
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531656
Sponsor's protocol ID
COG0203
Other IDs
R01AG065248
Status last verified
Aug 2026
First submitted
8 Aug 2022
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CT1812 in people with Early Alzheimer's Disease, run by Cognition Therapeutics at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scale. (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531656.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in