Donepezil and the Risk of Falls in Seniors With Cognitive Impairment

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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. Why older adults with cognitive problems fall more frequently is not completely understood. What is known, however, is that attention is a necessary cognitive resource for normal walking and impairments in attention are associated with increased risk of falls in older adults.

It has been suggested that cholinesterase inhibitors (ChEI), medications used for treatment of dementia, may improve motor function and walking (gait performance). Since ChEI are known to improve attention, we hypothesized that ChEI will reduce falls risk in people with MCI by improving their gait velocity, improving their balance, and reducing their gait variability; a well-established risk factor for falls.

In the proposed study, we will evaluate the effect of donepezil (ChEI) on gait velocity, gait variability, and the balance on 140 elderly individuals with MCI (70 intervention and 70 controls). Gait variables will be measured using an electronic walkway, and balance confidence using a validated scale (Activities-Specific Balance Confidence Scale; ABC) over four months.

By characterizing and understanding the effects of cognitive enhancers on fall risk in older adults with cognitive impairments, we will be able to pave the way for a new approach to fall prevention in this population. We would establish that medications that augment cognitive function could be a complementary therapeutic option for reducing fall risk in people with MCI. This may lead to new approaches to prevent and treat fall risk in this population, which will lead to improve the autonomy and quality of life of seniors in early stage of dementia, and a decreased burden for the Ontario health care system.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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