NCT03507790

A Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD). This Phase 2 study is designed to evaluate the safety of two doses of CT1812 administered once daily for 6 months in adults aged 50 to 85 who have been diagnosed with mild to moderate Alzheimer's disease. Randomized participants will receive 100 mg of CT1812, 300 mg of CT1812, or placebo once daily for 182 days. Exploratory endpoints that evaluate the effect of CT1812 on biomarkers are also included.

Conditions

• Mild to Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	CT1812	Active Study Drug
DRUG	Placebo	Non-active study drug

Timeline

• Start date: 2018-10-10
• Primary completion: 2024-05-29
• Completion: 2024-05-29
• First posted: 2018-04-25
• Last updated: 2025-08-11
• Results posted: 2025-08-11

Locations

32 sites across 5 countries: United States, Australia, Czechia, Netherlands, Spain

Regulatory

• FDA-regulated drug study