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

Last updated: September 16, 2025
Sponsor: Cognition Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

CT1812

Clinical Study ID

NCT05531656
COG0203
R01AG065248
  • Ages 50-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages 50-85 years.

  2. Diagnosis of either MCI due to AD or mild AD dementia.

  3. MMSE 20-30 (inclusive).

  4. Amyloid PET scan of the brain or CSF biomarkers consistent with AD.

  5. Neuroimaging (MRI) obtained during screening consistent with the clinical diagnosisof Alzheimer's disease, as based on central read.

Exclusion

Exclusion Criteria:

  1. Screening MRI of the brain indicative of significant abnormality.

  2. Clinically significant abnormalities in screening laboratory tests.

  3. Clinical or laboratory findings consistent with:

  4. Other primary degenerative dementia, (dementia with Lewy bodies,fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Downsyndrome, etc.).

  5. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateralsclerosis, etc.).

  6. Other infectious, metabolic or systemic diseases affecting the central nervoussystem (syphilis, present hypothyroidism, present vitamin B12, other laboratoryvalues etc.)

  7. A participant known to be actively infected with hepatitis B or hepatitis C atscreening. 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., HCVRNA negative) may be considered following discussion with the Medical Monitor.

  8. A current DSM-V diagnosis of active major depression or GDS > 6, schizophrenia, orbipolar disorder.

Study Design

Total Participants: 540
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 28, 2023
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Banner Alzheimer's Institute

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Site Not Available

  • Banner Sun Health Research Institute

    Sun City 5316201, Arizona 5551752 85351
    United States

    Site Not Available

  • University of California

    Irvine, California 92697
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California

    Irvine 5359777, California 5332921 92697
    United States

    Site Not Available

  • Stanford University

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • Sutter Institute for Medical Research

    Sacramento 5389489, California 5332921 95816
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20057
    United States

    Active - Recruiting

  • Howard University

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Georgetown University

    Washington D.C. 4140963, District of Columbia 4138106 20057
    United States

    Site Not Available

  • Howard University

    Washington D.C. 4140963, District of Columbia 4138106 20060
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Mayo Clinic,Jacksonville

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • JEM Research Institute

    Lake Worth, Florida 33462
    United States

    Site Not Available

  • K2 Medical Research, LLC

    Maitland, Florida 32751
    United States

    Site Not Available

  • Advanced Clinical Research Network, Corp

    Miami, Florida 33135
    United States

    Site Not Available

  • Charter Research

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33613
    United States

    Site Not Available

  • Conquest Research, LLC

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Brain Matters Research

    Delray Beach 4153132, Florida 4155751 33445
    United States

    Site Not Available

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Mayo Clinic,Jacksonville

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • JEM Research Institute

    Lake Worth 4161422, Florida 4155751 33462
    United States

    Site Not Available

  • K2 Medical Research, LLC

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • Advanced Clinical Research Network, Corp

    Miami 4164138, Florida 4155751 33135
    United States

    Site Not Available

  • Charter Research

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Headlands Research Orlando

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Brain Matters Research Stuart

    Stuart 4174201, Florida 4155751 34997
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • Conquest Research, LLC

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • Sanders-Brown Center on Aging

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Sanders-Brown Center on Aging

    Lexington 4297983, Kentucky 6254925 40504
    United States

    Site Not Available

  • John Hopkins University

    Baltimore 4347778, Maryland 4361885 21224
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Highlands Research Eastern MA

    Plymouth, Massachusetts 02360
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Highlands Research Eastern MA

    Plymouth 4947597, Massachusetts 6254926 02360
    United States

    Site Not Available

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan, Ann Arbor

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55901
    United States

    Active - Recruiting

  • Mayo Clinic, Rochester

    Rochester 5043473, Minnesota 5037779 55901
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas 5506956, Nevada 5509151 89106
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14620
    United States

    Site Not Available

  • Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14620
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

  • Case Western Reserve University / University Hospitals

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Case Western Reserve University / University Hospitals

    Beachwood 5146711, Ohio 5165418 44122
    United States

    Site Not Available

  • Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Central States Research, LLC

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Central States Research, LLC

    Tulsa 4553433, Oklahoma 4544379 74136
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Summit Headlands LLC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Summit Headlands LLC

    Portland 5746545, Oregon 5744337 97210
    United States

    Site Not Available

  • Abington Neurological Associates

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Abington Neurological Associates

    Abington 5177773, Pennsylvania 6254927 19001
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Butler Hospital

    Providence 5224151, Rhode Island 5224323 02906
    United States

    Site Not Available

  • Ralph H. Johnson VA MC

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Ralph H. Johnson VA MC

    Charleston 4574324, South Carolina 4597040 29401
    United States

    Site Not Available

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Houston Methodist Neurological Institute

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Texas Health Science Center

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53726
    United States

    Site Not Available

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53726
    United States

    Site Not Available

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