NCT05531656

A Study to Evaluate the Safety and Efficacy of CT1812 in 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.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Early Alzheimer's Disease

Interventions

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

Timeline

• Start date: 2023-06-28
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-09-08
• Last updated: 2025-09-22

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study