Rasagiline Rescue in Alzheimer's Disease Clinical Trial (R2)

• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: Rasagiline; Drug: Placebo	Phase 2

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	27 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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
Actual Study Start Date :	May 2015
Actual Primary Completion Date :	August 29, 2018
Actual Study Completion Date :	January 4, 2019

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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).	Drug: Placebo
Active Comparator: 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).	Drug: Rasagiline

Outcome Measures

Primary Outcome Measures :

1. The primary study endpoint is the change from baseline to Week 24 in regional glucose metabolism as measured by standard uptake units regional (SUVR) obtained through the 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET). [ Time Frame: 24 weeks ]
   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

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Ages Eligible for Study:	50 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Locations

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United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, Ohio
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Cleveland Clinic Lakewood Hospital
Lakewood, Ohio, United States, 44107

Sponsors and Collaborators

The Cleveland Clinic

Investigators

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Principal Investigator:	Jeffrey L Cummings, MD, ScD	The Cleveland Clinic

More Information

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Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT02359552 History of Changes
Other Study ID Numbers:	14-519
First Posted:	February 10, 2015
Last Update Posted:	May 8, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:

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Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders	Mental Disorders; Rasagiline; Monoamine Oxidase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Physiological Effects of Drugs