A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
NCT ID: NCT05531656
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
540 participants
INTERVENTIONAL
2023-06-28
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT1812 100 mg
CT1812 at a dose of 100 n=180 group
CT1812
Study Drug
CT1812 200 mg
CT1812 at a dose of 300mg, n=180 group
CT1812
Study Drug
Placebo
Placebo, n=180 group
Placebo
Non-active study drug
Interventions
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CT1812
Study Drug
Placebo
Non-active study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 diagnosis of Alzheimer's disease, as based on central read.
Exclusion Criteria
2. Clinically significant abnormalities in screening laboratory tests.
3. Clinical or laboratory findings consistent with:
1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down syndrome, etc.).
2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.).
3. Other infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12, other laboratory values etc.)
4. 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.
5. A current DSM-V diagnosis of active major depression or GDS \> 6, schizophrenia, or bipolar disorder.
50 Years
85 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Alzheimer's Clinical Trials Consortium
OTHER
Cognition Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Anthony Caggiano, MD
Role: STUDY_DIRECTOR
Cognition Therapeutics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
University of California
Irvine, California, United States
Stanford University
Palo Alto, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
Mayo Clinic,Jacksonville
Jacksonville, Florida, United States
JEM Research Institute
Lake Worth, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Advanced Clinical Research Network, Corp
Miami, Florida, United States
Charter Research
Orlando, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Brain Matters Research Stuart
Stuart, Florida, United States
University of South Florida
Tampa, Florida, United States
Conquest Research, LLC
Winter Park, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Sanders-Brown Center on Aging
Lexington, Kentucky, United States
John Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Highlands Research Eastern MA
Plymouth, Massachusetts, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Case Western Reserve University / University Hospitals
Beachwood, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Central States Research, LLC
Tulsa, Oklahoma, United States
Summit Headlands LLC
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Butler Hospital
Providence, Rhode Island, United States
Ralph H. Johnson VA MC
Charleston, South Carolina, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, United States
Vanderbilt University Medical Center Center for Cognitive Medicine
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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COG0203
Identifier Type: -
Identifier Source: org_study_id
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