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GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease

NCT03823404 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

Last updated 2023-02-23

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

COR388 capsule

BID (twice daily)

DRUG

Placebo capsule

BID

Sponsors & Collaborators

  • Cortexyme Inc.

    lead INDUSTRY

Principal Investigators

  • Karen Smith, MD · Quince Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2022-01-01
Completion
2022-01-01
FDA Drug
Yes

Countries

  • United States
  • France
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823404 on ClinicalTrials.gov