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

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 in participants diagnosed with early Alzheimer's disease.

Conditions

Early Alzheimer's Disease

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Study Overview

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Study Details

Study overview

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.

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.

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

Condition
Early Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Phoenix

Banner Alzheimer's Institute, Phoenix, Arizona, United States, 85006

Sun City

Banner Sun Health Research Institute, Sun City, Arizona, United States, 85351

Irvine

University of California, Irvine, California, United States, 92697

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Washington

Georgetown University, Washington, District of Columbia, United States, 20057

Washington

Howard University, Washington, District of Columbia, United States, 20060

Delray Beach

Brain Matters Research, Delray Beach, Florida, United States, 33445

Jacksonville

Mayo Clinic,Jacksonville, Jacksonville, Florida, United States, 32216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 diagnosis of Alzheimer's disease, as based on central read.
  • 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:
  • 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.

Ages Eligible for Study

50 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cognition Therapeutics,

Anthony Caggiano, MD, STUDY_DIRECTOR, Cognition Therapeutics

Study Record Dates

2027-04