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 |
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).
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
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
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