A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients Receiving Dopaminergic Therapy (GUHIITCog2012)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01497652
First received: December 20, 2011
Last updated: January 6, 2012
Last verified: October 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients Receiving Dopaminergic Therapy

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Montreal Cognitive Assessment [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Best value is 30 and Worst Value is 0. Scores for a series of subscales are not combined for a total overall score.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group Drug: Rasagiline
0.5 mg for two weeks, then 1 mg for 12 weeks.
Other Name: Azilect
Placebo Comparator: Placebo Group Drug: Rasagiline/Placebo
Will receive placebo pills each day for the entire 14 weeks.
Other Name: Sugar pill

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497652

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Teva Neuroscience, Inc.
Investigators
Principal Investigator: Fernando L Pagan, MD Georgetown University
  More Information

No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01497652     History of Changes
Other Study ID Numbers: GUHIITCog2012
Study First Received: December 20, 2011
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
Parkinson's Disease
Cognition
Rasagiline
MoCA
Mild Cognitive Impairment in Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Dopamine Agents
Rasagiline
Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014