A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic Therapy (RECOGNIZE)
Status and phase
Completed
Phase 4
Conditions
Parkinson's Disease
Treatments
Drug: Rasagiline/Placebo
Drug: Rasagiline
Details and patient eligibility
About
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.
Enrollment
34 patients
Sex
All
Ages
40+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
34 participants in 2 patient groups, including a placebo group
Treatment Group
Active Comparator group
Description:
Treatment group will receive Rasagiline (Azilect) 1mg daily
Treatment:
Drug: Rasagiline
Placebo Group
Placebo Comparator group
Description:
will receive placebo daily
Treatment:
Drug: Rasagiline/Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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