title: Can cognitive enhancers reduce the risk of falls in older people with mild cognitive impairment? A protocol for a randomised controlled double blind trial.
abstract: BACKGROUND
  Older adults with cognitive problems have a higher risk of falls, at least twice that of cognitively normal older adults. The consequences of falls in this population are very serious: fallers with cognitive problems suffer more injuries due to falls and are approximately five times more likely to be admitted to institutional care. Although the mechanisms of increased fall risk in cognitively impaired people are not completely understood, it is known that impaired cognitive abilities can reduce attentional resource allocation while walking. Since cognitive enhancers, such as cholinesterase inhibitors, improve attention and executive function, we hypothesise that cognitive enhancers may reduce fall risk in elderly people in the early stages of cognitive decline by improving their gait and balance performance due to an enhancement in attention and executive function.
  
  
  METHODS
  Double blinded randomized controlled trial with 6 months follow-up in 140 older individuals with Mild Cognitive Impairment (MCI). Participants will be randomized to the intervention group, receiving donepezil, and to the control group, receiving placebo. A block randomization by four and stratification based on fall history will be performed. Primary outcomes are improvements in gait velocity and reduction in gait variability. Secondary outcomes are changes in the balance confidence, balance sway, attention, executive function, and number of falls.
  
  
  CONCLUSIONS
  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. This RCT study will provide, for the first time, information regarding the effect of a medication designed to augment cognitive functioning have on the risk of falls in older adults with Mild Cognitive Impairment. We expect a significant reduction in the risk of falls in this vulnerable population as a function of the reduced gait variability achieved by treatment with cognitive enhancers. This study may contribute to a new approach to prevent and treat fall risk in seniors in early stages of dementia.
  
  
  BACKGROUND
  The protocol for this study is registered with the Clinical Trials Registry, identifier number: NCT00934531 http://www.clinicaltrials.gov.
authors.affiliation: Department of Medicine, Division of Geriatric Medicine, Parkwood Hospital, University of Western Ontario, London, ON, Canada. Manuel.MonteroOdasso@sjhc.london.on.ca
authors.forename: Manuel
authors.initials: M
authors.lastname: Montero-Odasso
authors.forename: Jennie L
authors.initials: JL
authors.lastname: Wells
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Borrie
authors.forename: Mark
authors.initials: M
authors.lastname: Speechley
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use; D002985:Clinical Protocols; D003072:Cognition Disorders / Q000150:complications / Q000188:drug therapy*; D055812:Community-Based Participatory Research; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D005684:Gait; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D018579:Patient Selection; D010880:Piperidines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil
references.citation: J Am Geriatr Soc. 2009 Feb;57(2):359-60
references.pmid: 19207156
references.citation: Gerontology. 2005 Jan-Feb;51(1):48-52
references.pmid: 15591756
references.citation: J Am Geriatr Soc. 2003 Oct;51(10):1466-71
references.pmid: 14511170
references.citation: BMC Musculoskelet Disord. 2004 May 17;5:13
references.pmid: 15147583
references.citation: J Clin Psychopharmacol. 2004 Jun;24(3):354-6
references.pmid: 15118497
references.citation: Int Psychogeriatr. 2001;13 Supp 1:169-75
references.pmid: 11892964
references.citation: J Am Geriatr Soc. 2005 Mar;53(3):410-5
references.pmid: 15743282
references.citation: J Neural Transm (Vienna). 2007;114(10):1259-64
references.pmid: 17557130
references.citation: Neuroepidemiology. 2006;26(1):52-60
references.pmid: 16254454
references.citation: N Engl J Med. 1994 Sep 29;331(13):821-7
references.pmid: 8078528
references.citation: N Engl J Med. 2005 Jun 9;352(23):2379-88
references.pmid: 15829527
references.citation: Ann Rheum Dis. 1990 Mar;49(3):201
references.pmid: 2353984
references.citation: Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472
references.pmid: 18058946
references.citation: J Neurol Sci. 2006 Oct 25;248(1-2):205-9
references.pmid: 16759668
references.citation: J Am Geriatr Soc. 2001 May;49(5):664-72
references.pmid: 11380764
references.citation: J Intern Med. 2004 Sep;256(3):183-94
references.pmid: 15324362
references.citation: J Neuroeng Rehabil. 2005 Jul 20;2:19
references.pmid: 16033650
references.citation: Arch Phys Med Rehabil. 2006 Dec;87(12):1648-52
references.pmid: 17141647
references.citation: Arch Phys Med Rehabil. 2007 Jan;88(1):50-3
references.pmid: 17207675
references.citation: N Engl J Med. 1988 Dec 29;319(26):1701-7
references.pmid: 3205267
references.citation: Can J Aging. 2005 Fall;24(3):261-74
references.pmid: 16421850
references.citation: J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1479-84
references.pmid: 16227534
references.citation: Gait Posture. 2003 Feb;17(1):68-74
references.pmid: 12535728
references.citation: Lancet. 2001 Apr 14;357(9263):1191-4
references.pmid: 11323066
references.citation: J Am Geriatr Soc. 2005 Dec;53(12):2190-4
references.pmid: 16398908
references.citation: J Aging Phys Act. 2008 Jul;16(3):292-315
references.pmid: 18660552
references.citation: Arch Neurol. 1999 Mar;56(3):303-8
references.pmid: 10190820
references.citation: Neurology. 1997 Apr;48(4):955-8
references.pmid: 9109884
references.citation: Lancet. 2002 Dec 14;360(9349):1963-5
references.pmid: 12493278
references.citation: Lancet. 2000 Jan 15;355(9199):225-8
references.pmid: 10675135
references.citation: Lancet. 1997 Mar 1;349(9052):617
references.pmid: 9057736
references.citation: J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34
references.pmid: 7814786
references.citation: Arch Neurol. 2003 Oct;60(10):1385-9
references.pmid: 14568808
references.citation: CMAJ. 1994 Mar 15;150(6):899-913
references.pmid: 8131123
references.citation: Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005593
references.pmid: 16437532
references.citation: Scand J Rheumatol Suppl. 1987;65:31-9
references.pmid: 3317807
references.citation: BMJ. 2003 Jan 11;326(7380):73
references.pmid: 12521968
references.citation: J Gerontol. 1987 Jul;42(4):412-7
references.pmid: 3598089
references.citation: Ann Intern Med. 2001 Apr 17;134(8):663-94
references.pmid: 11304107
references.citation: J Gerontol A Biol Sci Med Sci. 1996 Jan;51(1):M37-43
references.pmid: 8548512
references.citation: Arthritis Rheum. 1991 May;34(5):505-14
references.pmid: 2025304
references.citation: Gerontology. 2008;54(2):106-15
references.pmid: 18259094
references.citation: J Am Geriatr Soc. 2005 Apr;53(4):695-9
references.pmid: 15817019
references.citation: Brain. 2000 Sep;123 ( Pt 9):1767-83
references.pmid: 10960043
references.citation: BMJ. 2007 Jan 13;334(7584):82
references.pmid: 17158580
references.citation: J Psychiatr Res. 1982-1983;17(1):37-49
references.pmid: 7183759
references.citation: Gait Posture. 2002 Aug;16(1):1-14
references.pmid: 12127181
references.citation: Psychopharmacol Bull. 1988;24(4):709-11
references.pmid: 3249773
references.citation: Phys Ther. 2008 Apr;88(4):449-59
references.pmid: 18218822
references.citation: Phys Ther. 2008 Dec;88(12):1482-91
references.pmid: 18820094
references.citation: Gait Posture. 2005 Feb;21(2):178-85
references.pmid: 15639397
references.citation: Clin Neuropharmacol. 2007 Mar-Apr;30(2):63-71
references.pmid: 17414938
references.citation: J Am Geriatr Soc. 2008 May;56(5):946-7
references.pmid: 18454755
references.citation: Arch Neurol. 2001 Dec;58(12):1985-92
references.pmid: 11735772
references.citation: J Gerontol. 1991 May;46(3):M69-76
references.pmid: 2030269
references.citation: Arch Neurol. 2004 Dec;61(12):1852-6
references.pmid: 15596605
references.citation: Brain. 1994 Aug;117 ( Pt 4):715-28
references.pmid: 7922459
references.citation: Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001190
references.pmid: 16437430
references.citation: Curr Opin Neurol. 2002 Aug;15(4):401-7
references.pmid: 12151835
references.citation: J Intern Med. 2004 Sep;256(3):240-6
references.pmid: 15324367
references.citation: Exp Brain Res. 2005 Aug;164(4):541-8
references.pmid: 15864565