A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy

The present pilot study is designed to assess the extent to which rasagiline may improve cognition in Parkinson's disease patients requiring dopaminergic therapy. The primary objective is to assess improvement in the Montreal Cognitive Assessment (MoCA) in patients who have been on rasagiline at 1mg daily for twelve weeks. The secondary objective is to assess changes in the SCOPA-COG, FAB, and UPDRS II & III at the end of week 14.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women aged 40 or older with idiopathic Parkinson's disease on stable dopaminergic therapy for at least 1 month. The UK Brain Bank Criteria will be used to establish the diagnosis of Parkinson's disease. Women must be post menopausal or agree to avoid pregnancy. Modified Hoehn & Yahr staging < 3 and MoCA score must be greater than 21 but less than 28. Geriatric Depression Scale (GDS) is a sensitive and specific screen for depression in the Parkinson's disease population. GDS scores of < 5 will be included in the study.

Exclusion criteria

Patients with secondary dementia, severe depression and atypical Parkinson's syndromes or Parkinson's plus will be excluded from the study. Patients on acetylcholine esterase or NMDA inhibitor medication will be excluded from the study. Patients with history of brain surgery for Parkinson's disease, stroke or significant head injury, active epilepsy will be excluded. Patients on Amantidine, neuroleptics, metoclopramide, alphamethyldopa within the last 6 months will be excluded. Individuals using meperidine, and tramadol will be excluded. Patients with congestive heart failure or myocardial infarction will also be excluded to avoid vascular dementia.

Treatment and study plan

Rasagiline/Placebo

Drug

Will receive placebo pills each day for the entire 14 weeks.

Other names: Sugar pill

Rasagiline

Drug

0.5 mg for two weeks, then 1 mg for 12 weeks.

Other names: Azilect

Primary outcomes

Montreal Cognitive Assessment

Time frame: 14 Weeks

Best value is 30 and Worst Value is 0. Scores for a series of subscales are not combined for a total overall score.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

Teva Neuroscience, Inc.

Registry information

Acronym: RECOGNIZE

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Dec 22, 2011
Registry last updated: Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed