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Donepezil and the Risk of Falls in Seniors With Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00934531
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Manuel Montero Odasso, Lawson Health Research Institute

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. 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 or disease Intervention/treatment Phase
Falls Gait Balance Mild Cognitive Impairment (MCI) Drug: Donepezil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2009
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Improvement in: 1. Balance confidence 2. Balance sway 3. Attention 4. Executive function 5. Reduction of number of Falls. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934531


Locations
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Canada, Ontario
St. Joseph's Health Care London, Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Manuel Montero Odasso, MD, PhD The University of Western Ontario, Dept. of Medicine, Div. of Geriatric Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manuel Montero Odasso, Geriatrician/Clinician Scientist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00934531    
Other Study ID Numbers: R-09-427
16086 ( Other Identifier: REB )
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Keywords provided by Manuel Montero Odasso, Lawson Health Research Institute:
Mild Cognitive Impairment (MCI)
Falls
donepezil
gait variability
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents