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

Brief Summary:
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate AD dementia.

Detailed Description:
This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable AD dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The study will enroll approximately 573 generally healthy male and female subjects ≥55 and ≤80 years of age. Enrolled subjects must have a documented diagnosis of mild to moderate AD dementia. The subject should not have other conditions or brain imaging abnormalities that can explain the symptoms of dementia. All subjects will be encouraged to have LPs (during screening, week 24 and week 48) in the absence of medical conditions that can increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood will be analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis [Pg]). A subset of sites will monitor subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 573 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease
Estimated Study Start Date: April 24, 2019
Estimated Primary Completion Date: December 31, 2021
Estimated Study Completion Date: December 31, 2022

Arm:
- Experimental: COR388 80 mg bid
- Experimental: COR388 40 mg bid
- Placebo Comparator: Placebo bid