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

NCT01497652 | Completed Phase 4

• 1 other identifier: IIT-TN-067
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Cognition; Rasagiline; MoCA; Mild Cognitive Impairment in Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment

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

  14 Weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Treatment group will receive Rasagiline (Azilect) 1mg daily

Drug: Rasagiline

Placebo Group

PLACEBO COMPARATOR

will receive placebo daily

Drug: Rasagiline/Placebo

Interventions

Rasagiline/Placebo DRUG

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

Also known as: Sugar pill

Placebo Group

Rasagiline DRUG

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

Also known as: Azilect

Treatment Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgetown University: lead
• Teva Neuroscience, Inc.: collaborator

Study Sites (1)

Georgetown University Hospital

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

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline; Sugars

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Fernando L Pagan, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

US (1)