Phase 3
N=643
GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03823404 ↗Enrolled (actual)
643
Serious AEs
10.0%
Results posted
Feb 2023
Primary outcome: Primary: Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) — 23.7; 23.4; 23.6; 26.6 score on a scale — p=<0.0455
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- COR388 capsule (Drug); Placebo capsule (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Cortexyme Inc.
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) |
23.7; 23.4; 23.6; 26.6; 27.9; 28.4 | <0.0455 sig |
| PRIMARY Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL) |
59.9; 60.1; 60.4; 55.4; 54.4; 55.5 | <0455 |
| SECONDARY Clinical Dementia Rating-Sum of Boxes (CDR-SB) |
5.7; 6.0; 5.9; 7.2; 7.2; 7.4 | — |
| SECONDARY Mini-Mental State Examination (MMSE) |
18.3; 18.4; 18.2; 16.9; 16.4; 16.2 | — |
| SECONDARY Neuropsychiatric Inventory (NPI) |
6.7; 8.2; 8.1; 10.7; 9.2; 10.4 | — |
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.
Eligibility Criteria
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 3 x upper limit of normal (ULN), aspartate aminotransferase >3 x ULN, or history of clinically significant liver disease in the Investigator's judgment.
- Hemoglobin ≤10 g/dl.
- Creatinine clearance (CL) of 8.
- 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.
Data sourced from ClinicalTrials.gov (NCT03823404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.