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:
Georgetown University
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
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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
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 June 17, 2013