GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease
Status
Recruiting
Start date
03/28/2019
Healthy
No
Contact
Michael J Detke, MD, PhD
415-910-5717
Age
55 Years
— 80 Years
Gender
All
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.
Overview
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.
The study will consist of 3 periods: a screening period of up to 6 weeks, a treatment period of up to 48 weeks, and a safety follow-up period of 6 weeks.
Eligibility Criteria
Key Inclusion Criteria:
Subject has probable AD dementia according to the NIA-AA criteria.
Subject has an 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:
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.
Hemoglobin ≤10 g/dl.
Creatinine clearance (CL) of <45 ml/min.
Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) >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.
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