Status:
COMPLETED
Donepezil and the Risk of Falls in Seniors With Cognitive Impairment
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Falls
Gait
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Compared with cognitively normal older adults, those with mild cognitive problems (MCI) have a two-fold higher rate of falls, sustain more fractures, and have a higher rate of mortality due to falls. ...
Detailed Description
Older adults with cognitive problems have a higher risk of falls, with annual incidence of around 60-80%; at least twice that of cognitively normal older adults. The consequences of falls in this popu...
Eligibility Criteria
Inclusion
- Age 65-100
- Male or Female
- Having Mild Cognitive Impairment (diagnosed using criteria validated by Petersen et. al)
- Acceptable Body Mass Index (BMI) range: 18-30
- Acceptable blood pressure (Systolic: 110-160, Diastolic: 50-110)
- Able to walk independently 10 meters without any gait aid
- Able to travel to Aging Brain and Memory Clinic for the assessments
Exclusion
- Unable to understand English
- Low body weight (less than 99lb/45kg)
- Possible diagnosis of Alzheimer's Disease
- Use of herbal preparations such as St. John's Wort and ginko biloba
- History of drug or alcohol abuse/dependence
- History of psychiatric illness within the last two years, including depression
- Parkinsonism or any neurological disorder with residual motor deficit (e.g.: stroke, epilepsy)
- Musculoskeletal disorder detected by clinical examination which affects gait performance
- Active osteoarthritis affecting the lower limbs (American College of Rheumatology criteria)
- Use of psychotropic medication, which can affect motor performance
- Use of an anticholinergic agent (benztropines), other acetylcholinesterase inhibitors or cholinergic agents (bethanechol)
- Depression (score above 8/15 on the Geriatric Depression Scale - GDS)
- Comorbidities which may contradict use of ChEIs
- History of chronic bradycardia or sick sinus syndrome
- Severe COPD and/or asthma
- History of seizure disorders
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00934531
Start Date
September 1 2009
End Date
January 1 2019
Last Update
January 7 2019
Active Locations (1)
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1
St. Joseph's Health Care London, Parkwood Hospital
London, Ontario, Canada, N6C 5J1