Rasagiline Rescue in Alzheimer's Disease Clinical Trial
NCT ID: NCT02359552
Last Updated: 2020-11-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2015-05-31
2019-01-04
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
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).
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).
Rasagiline
Interventions
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Rasagiline
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
90 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Jeffrey L Cummings, MD, ScD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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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
Countries
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References
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Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S33-9.
Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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14-519
Identifier Type: -
Identifier Source: org_study_id