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


Trial ID: NCT03823404


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.

Official Title

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

Stanford Investigator(s)

Sharon Sha, MD, MS
Sharon Sha, MD, MS

Clinical Professor, Neurology & Neurological Sciences


Key Inclusion Criteria:

   - Subject has probable AD dementia according to the NIA-AA criteria.

   - Subject has an Mini-Mental State Examination (MMSE) score 12 and 24 inclusive at both
   screening and Visit 2 and a ≤3-point difference between these visits.

   - Subject has brain MRI scan consistent with the diagnosis of AD performed during the
   screening period. Computed Tomography scan can be used only if the subject has an
   absolute contraindication for MRI.

   - Subject has a Modified Hachinski score ≤4 at screening.

   - Subjects with background symptomatic therapy with acetylcholine esterase inhibitors,
   and/or memantine, are allowed as long as the dose has been stable for 90 days prior to
   screening and no changes are planned during the study.

   - Subject has a primary caregiver willing to accept responsibility for supervising the
   treatment (e.g., administering study drug) and assessing the condition of the subject
   throughout the study in accordance with all protocol requirements.

   - Subject has body mass index <38 kg/m2 at Screening

Key Exclusion Criteria:

   - Subject has imaging consistent with a dementia diagnosis other than AD.

   - Subject has had an increase or restoration of cognition based on medical history.

   - Subject with history or current evidence of major psychiatric illness such as
   schizophrenia, bipolar disorder, or major depressive disorder that may interfere with
   the patient's ability to perform the study and all assessments. Note: Mild depression
   or depressive mood arising in the context of AD are not criteria for exclusion. The
   use of anti-depressants or the use of anti epileptic medication for non
   seizure-related treatment is allowed if the dose has remained stable for at least 60
   days prior to enrollment.

   - Subject has any of the following laboratory findings at screening:

      1. Alanine aminotransferase >3 x upper limit of normal (ULN), aspartate
      aminotransferase >3 x ULN, or history of clinically significant liver disease in
      the Investigator's judgment.

      2. Hemoglobin ≤10 g/dl.

      3. Creatinine clearance (CL) of <45 ml/min.

      4. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >8.

      5. Positive blood screen for Human Immunodeficiency Virus (HIV 1 and 2), Hepatitis B
      surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.


drug: COR388 capsule

drug: Placebo capsule


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305