Donepezil and the Risk of Falls in Seniors With Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Manuel Montero Odasso, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00934531
First received: July 7, 2009
Last updated: October 2, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Falls
Gait
Balance
Mild Cognitive Impairment (MCI)
Drug: Donepezil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Can Cognitive Enhancers Reduce the Risk of Falls in Older People With Mild Cognitive Impairment? A Randomized Controled Trial

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Improvements in gait performance (Combined outcome: increase in gait velocity-cm/second- and/or reduction in gait variability assessed as standard deviation (SD) and coefficient of variation (CoV). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in: 1. Balance confidence 2. Balance sway 3. Attention 4. Executive function 5. Reduction of number of Falls. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donepezil
participants with MCI receiving donepezil
Drug: Donepezil

Participants with MCI will be randomized to either the experimental (donepezil) or placebo arm of the study.

Experimental Arm: Participants with MCI will receive 5 mg/day of donepezil p.o. for 4 weeks, and thereafter 10 mg/day of donepezil p.o. for a period of 5 months, yielding a total period of intervention of 6 months from baseline.

Placebo Arm: Participants with MCI will receive a matched placebo p.o. for 4 weeks, and thereafter will receive a new matched placebo p.o. for the next 5 months, yielding a total period of intervention of 6 months from baseline.

Other Name: donepezil (Aricept)
Placebo Comparator: Placebo
Participants with MCI receiving placebo
Drug: Donepezil

Participants with MCI will be randomized to either the experimental (donepezil) or placebo arm of the study.

Experimental Arm: Participants with MCI will receive 5 mg/day of donepezil p.o. for 4 weeks, and thereafter 10 mg/day of donepezil p.o. for a period of 5 months, yielding a total period of intervention of 6 months from baseline.

Placebo Arm: Participants with MCI will receive a matched placebo p.o. for 4 weeks, and thereafter will receive a new matched placebo p.o. for the next 5 months, yielding a total period of intervention of 6 months from baseline.

Other Name: donepezil (Aricept)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934531

Locations
Canada, Ontario
St. Joseph's Health Care London, Parkwood Hospital Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Manuel Montero Odasso, MD, PhD    (519) 685-4292 ext 42369    mmontero@uwo.ca   
Principal Investigator: Manuel Montero Odasso, MD, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Manuel Montero Odasso, MD, PhD The University of Western Ontario, Dept. of Medicine, Div. of Geriatric Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Manuel Montero Odasso, Geriatrician/Clinician Scientist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00934531     History of Changes
Other Study ID Numbers: R-09-427, 16086
Study First Received: July 7, 2009
Last Updated: October 2, 2012
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Mild Cognitive Impairment (MCI)
Falls
donepezil
gait variability

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014