Rasagiline Rescue in Alzheimer's Disease Clinical Trial

• Status: Completed
• Trial end date: 2019-01-04
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Rasagiline

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