Rasagiline Rescue in Alzheimer's Disease Clinical Trial



Status:Active, not recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 90
Updated:4/17/2018
Start Date:May 2015
End Date:February 15, 2019

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A 24-week, Three-site, Randomized, Double Blind, Placebo Controlled, Parallel Group, Proof-of-concept Study to Evaluate Rasagiline in the Regional Brain Metabolism on FDG PET in Patients With Mild to Moderate Alzheimer's Disease

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).

The study consists of two phases: a 24 week double blind placebo controlled treatment period
and a 4 week follow up period. Patients will be randomized in a 1: 1 ratio at baseline to
receive either Rasagiline or matching placebo

The study drug will be given as 0.5 mg dose once daily for the 4 weeks, then increases to 1
mg daily for the next 20 weeks. A total of 50 subjects will be enrolled: 25 will receive
Rasagiline and 25 will receive matching placebo for the 24-week treatment period.

Primary objective is to determine if exposure to 1 mg of Rasagiline daily is associated with
improved regional brain metabolism in the treatment group compared to the placebo group in
Alzheimer's Disease patients

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
We found this trial at
3
sites
Lakewood, Ohio 44107
Phone: 216-227-2438
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Lakewood, OH
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Cleveland, Ohio 44195
Phone: 216-445-7273
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Cleveland, OH
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Las Vegas, Nevada 89106
Phone: 855-568-7886
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Las Vegas, NV
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