Clinical trial NCT02359552: Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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

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

Primary outcomes:
measure: Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET).
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) Score
timeFrame: Mean change in scores from baseline to week 24
measure: Change in MMSE (Mini Mental Status Examination) Score
timeFrame: Mean change in scores from baseline to week 24
measure: Change in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) Score
timeFrame: Mean change in scores from baseline to week 24
measure: Change in NPI (Neuropsychiatric Inventory) Score
timeFrame: Mean change in scores from baseline to week 24
measure: Change in Digit Span
timeFrame: Mean change in scores from baseline to week 24
measure: Change in COWAT (Controlled Oral Word Association Test) Score
timeFrame: Mean change in scores from baseline to week 24
measure: Change in QoL-AD (Quality of Life - Alzheimer's Disease) Score
timeFrame: This assessment will be performed at the Baseline and Week 24 visits.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Lakewood
country: United States
facility: Cleveland Clinic Lakewood Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jeffrey L Cummings, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.