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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497652
First Posted: December 22, 2011
Last Update Posted: December 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Teva Neuroscience, Inc.
Information provided by (Responsible Party):
Georgetown University
  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
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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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.


Enrollment: 34
Study Start Date: January 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Azilect
Placebo Comparator: Placebo Group
will receive placebo daily
Drug: Rasagiline/Placebo
Will receive placebo pills each day for the entire 14 weeks.
Other Name: Sugar pill

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01497652     History of Changes
Other Study ID Numbers: IIT-TN-067
First Submitted: December 20, 2011
First Posted: December 22, 2011
Last Update Posted: December 16, 2015
Last Verified: December 2015

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

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