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Caffeine as a Therapeutic Agent in Parkinson's Disease
Parkinson's disease is a common neurodegenerative disorder in which patients experience progressive motor disability and many disabling non-motor symptoms. Recent studies have consistently found that people who do not use caffeine are at higher risk of developing Parkinson's disease. This suggests that caffeine may have potential as a treatment for PD. In a pilot study of caffeine for daytime sleepiness in PD, there was evident benefit on the motor manifestations of disease. There have been other lines of evidence that have suggested caffeine could be useful in PD. This study is to evaluate the efficacy of caffeine 200 mg BID vs matching placebo for motor and non-motor aspects of disease. This will be in three stages. In the first six-month stage, medications will be held constant, to see whether caffeine does have motor benefits. Then we will perform a four-year extension stage to define if the effects of caffeine persist (or even magnify), and to see if caffeine helps reduce dose of other PD meds and/or prevents their side effects. Finally, we will finish with a six-month stage in which we will place all patients on caffeine - this will allow us to assess caffeine's use in later disease, but more importantly, will assess whether early use of caffeine produces long term changes beyond its immediate effects.
Age
45 - 75 years
Sex
ALL
Healthy Volunteers
No
Parana Parkinson Association - Pontifical Catholic University of Parana
Curitiba, Paraná, Brazil
Heritage Medical Research Clinic - University of Calgary
Calgary, Alberta, Canada
UBC Hospital - Pacific Parkinson's Research Centre
Vancouver, British Columbia, Canada
Movement Disorder Clinic - Deer Lodge Centre
Winnipeg, Manitoba, Canada
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Toronto western Hospital - Movement Disorders Research Centre
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Start Date
April 1, 2014
Primary Completion Date
May 1, 2016
Completion Date
December 1, 2016
Last Updated
March 22, 2017
119
ACTUAL participants
Caffeine
DRUG
Placebo
DRUG
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
NCT02119611
NCT07310264
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976