NCT03493282

Effect of CT1812 Treatment on Brain Synaptic Density

A Pilot Synaptic Vesicle Glycoprotein 2A (SV2A) PET Study to Evaluate the Effect of CT1812 Treatment on Synaptic Density in Participants With Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Study to Evaluate the Safety and Tolerability of Oral CT1812 in Subjects with Mild to Moderate Alzheimer's Disease.

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled, parallel group study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the safety and tolerability of oral CT1812, administered for up 180 days for the Primary study and another 180 days for the double-blind extension study. Each participant and caregiver participated in a screening period of up to 60 days, followed by the primary double-blind treatment period of 24 weeks (169 days +/-2) followed by an optional double-blind extension treatment period of another 24 weeks (337 days +/-2).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Active Treatment- CT1812 100 mg	CT1812
DRUG	Active Treatment- CT1812 300 mg	CT1812
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2018-03-28
• Primary completion: 2020-10-16
• Completion: 2020-10-16
• First posted: 2018-04-10
• Last updated: 2023-09-07
• Results posted: 2023-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study