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

Sponsor

Georgetown University (Other)

Overall Status

Completed

CT.gov ID

NCT01497652

Collaborator

Teva Neuroscience, Inc. (Industry)

Enrollment

Location

Arms

37.9

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Rasagiline/Placebo Drug: Rasagiline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group Treatment group will receive Rasagiline (Azilect) 1mg daily	Drug: Rasagiline 0.5 mg for two weeks, then 1 mg for 12 weeks. Other Names: Azilect
Placebo Comparator: Placebo Group will receive placebo daily	Drug: Rasagiline/Placebo Will receive placebo pills each day for the entire 14 weeks. Other Names: Sugar pill

Arm

Intervention/Treatment

Active Comparator: Treatment Group

Treatment group will receive Rasagiline (Azilect) 1mg daily

Drug: Rasagiline

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

Other Names:

Azilect

Placebo Comparator: Placebo Group

will receive placebo daily

Drug: Rasagiline/Placebo

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

Other Names:

Sugar pill

Outcome Measures

Primary Outcome Measures

Montreal Cognitive Assessment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.