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

Purpose

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.

Condition

  • Early Alzheimer's Disease

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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: 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
CT1812 100 mg 		CT1812 at a dose of 100 n=180 group
  • Drug: CT1812
    Study Drug
    Other names:
    • Study Drug Active
Active Comparator
CT1812 200 mg 		CT1812 at a dose of 300mg, n=180 group
  • Drug: CT1812
    Study Drug
    Other names:
    • Study Drug Active
Placebo Comparator
Placebo 		Placebo, n=180 group
  • Drug: Placebo
    Non-active study drug
    Other names:
    • Matching Placebo

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

More Details

Status
Recruiting
Sponsor
Cognition Therapeutics

Study Contact

Theresa Devins, DrPH, MS
888-745-1050
clinicaltrials@cogrx.com

Detailed 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.