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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT01497652
• Date of registration: 20/12/2011
• Prospective Registration: Yes
• Primary sponsor: Georgetown University
• Public title: A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy RECOGNIZE
• Scientific title: A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy
• Date of first enrolment: January 2012
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01497652
• 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
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Fernando L Pagan, MD
• Affiliation: Georgetown University

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Rasagiline/Placebo

Drug: Rasagiline

Primary Outcome(s)

Montreal Cognitive Assessment [Time Frame: 14 Weeks]

Secondary ID(s)

IIT-TN-067

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Teva Neuroscience, Inc.