CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 643 enrolled
Drug / intervention
COR388 capsule +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03823404
NCT03823404Phase 3Completed

GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease

Cortexyme Inc.·interventional·Posted Jan 30, 2019·Updated Feb 23, 2023

In Brief

A Phase 3 clinical trial evaluating COR388 capsule and Placebo capsule for Alzheimer Disease. Completed, enrolled 643 participants across 93 sites in 6 countries.

Detailed Summary

This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Netherlands, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartMar 28, 2019
Primary CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.4 years ago

Interventions

COR388 capsuledrug

BID (twice daily)

Placebo capsuledrug

BID