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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Early Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT05531656

Run by

Cognition Therapeutics

People needed

540

Starts

2023-06-28

Expected to finish

2027-04-01

Last updated by the study team

2025-09-22

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.