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

Last updated: March 26, 2025
Sponsor: Cognition Therapeutics
Overall Status: Active - 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

    Active - Recruiting

  • Banner Alzheimer's Institute

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Banner Sun Health Research Institute

    Sun City, Arizona 85351
    United States

    Active - Recruiting

  • University of California

    Irvine, California 92697
    United States

    Active - Recruiting

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Georgetown University

    Washington, District of Columbia 20057
    United States

    Active - Recruiting

  • Howard University

    Washington, District of Columbia 20060
    United States

    Active - Recruiting

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Active - Recruiting

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Mayo Clinic,Jacksonville

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • JEM Research Institute

    Lake Worth, Florida 33462
    United States

    Active - Recruiting

  • K2 Medical Research, LLC

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Advanced Clinical Research Network, Corp

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Charter Research

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Conquest Research, LLC

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Sanders-Brown Center on Aging

    Lexington, Kentucky 40504
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Highlands Research Eastern MA

    Plymouth, Massachusetts 02360
    United States

    Active - Recruiting

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55901
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Case Western Reserve University / University Hospitals

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Central States Research, LLC

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Summit Headlands LLC

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Abington Neurological Associates

    Abington, Pennsylvania 19001
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Butler Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

  • Ralph H. Johnson VA MC

    Charleston, South Carolina 29401
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Wisconsin

    Madison, Wisconsin 53726
    United States

    Active - Recruiting

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