Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Completed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of concept three-site study, to evaluate the effect of Rasagiline in the regional brain metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).
Key facts
- Study ID
- NCT02359552
- Run by
- The Cleveland Clinic
- People needed
- 50
- Starts
- 2015-05-01
- Expected to finish
- 2019-01-04
- Last updated by the study team
- 2020-11-10
Who can join
Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
- Cleveland Clinic Main Campus — Cleveland, Ohio, United States
- Cleveland Clinic Lakewood Hospital — Lakewood, Ohio, United States
Full record on ClinicalTrials.gov
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