Rasagiline Rescue in Alzheimer's Disease Clinical Trial (R2)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Males or females 50 to 90 of age inclusive.
- Diagnosis of probable AD (NINCDS-ADRDA criteria)
- Positive fluoro-deoxyglucose PET ([18F]-FDG PET) scan compatible with AD as determined by the ADM Diagnostics LLC (ADMdx) Criteria at screening
- Mini Mental Status Exam = 12 - 22 (inclusive)
- Must have a study partner who is able and willing to comply with all required study procedures.
- Have at least eight years of education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others in English.
- If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of these agents has been stable for at least 3 months prior to screening
Exclusion Criteria:
- Any non-AD neurological disease
- MRI findings indication of a non-AD diagnosis
- Screening laboratory studies that are 1.5 times above or below the highest and lowest range of normal for each test respectively
- History of melanoma; history of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer
Sites / Locations
- Cleveland Clinic Lou Ruvo Center for Brain Health
- Cleveland Clinic Main Campus
- Cleveland Clinic Lakewood Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Rasagiline
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment. Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).
Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment. Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).