Can cognitive enhancers reduce the risk of falls in older people with mild cognitive impairment? A protocol for a randomised controlled double blind trial.
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.
Montero-Odasso
Manuel
M
Department of Medicine, Division of Geriatric Medicine, Parkwood Hospital, University of Western Ontario, London, ON, Canada. Manuel.MonteroOdasso@sjhc.london.on.ca
Wells
Jennie L
JL
Borrie
Michael J
MJ
Speechley
Mark
M
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
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D000077265:Donepezil
J Am Geriatr Soc. 2009 Feb;57(2):359-60
19207156
Gerontology. 2005 Jan-Feb;51(1):48-52
15591756
J Am Geriatr Soc. 2003 Oct;51(10):1466-71
14511170
BMC Musculoskelet Disord. 2004 May 17;5:13
15147583
J Clin Psychopharmacol. 2004 Jun;24(3):354-6
15118497
Int Psychogeriatr. 2001;13 Supp 1:169-75
11892964
J Am Geriatr Soc. 2005 Mar;53(3):410-5
15743282
J Neural Transm (Vienna). 2007;114(10):1259-64
17557130
Neuroepidemiology. 2006;26(1):52-60
16254454
N Engl J Med. 1994 Sep 29;331(13):821-7
8078528
N Engl J Med. 2005 Jun 9;352(23):2379-88
15829527
Ann Rheum Dis. 1990 Mar;49(3):201
2353984
Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472
18058946
J Neurol Sci. 2006 Oct 25;248(1-2):205-9
16759668
J Am Geriatr Soc. 2001 May;49(5):664-72
11380764
J Intern Med. 2004 Sep;256(3):183-94
15324362
J Neuroeng Rehabil. 2005 Jul 20;2:19
16033650
Arch Phys Med Rehabil. 2006 Dec;87(12):1648-52
17141647
Arch Phys Med Rehabil. 2007 Jan;88(1):50-3
17207675
N Engl J Med. 1988 Dec 29;319(26):1701-7
3205267
Can J Aging. 2005 Fall;24(3):261-74
16421850
J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1479-84
16227534
Gait Posture. 2003 Feb;17(1):68-74
12535728
Lancet. 2001 Apr 14;357(9263):1191-4
11323066
J Am Geriatr Soc. 2005 Dec;53(12):2190-4
16398908
J Aging Phys Act. 2008 Jul;16(3):292-315
18660552
Arch Neurol. 1999 Mar;56(3):303-8
10190820
Neurology. 1997 Apr;48(4):955-8
9109884
Lancet. 2002 Dec 14;360(9349):1963-5
12493278
Lancet. 2000 Jan 15;355(9199):225-8
10675135
Lancet. 1997 Mar 1;349(9052):617
9057736
J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34
7814786
Arch Neurol. 2003 Oct;60(10):1385-9
14568808
CMAJ. 1994 Mar 15;150(6):899-913
8131123
Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005593
16437532
Scand J Rheumatol Suppl. 1987;65:31-9
3317807
BMJ. 2003 Jan 11;326(7380):73
12521968
J Gerontol. 1987 Jul;42(4):412-7
3598089
Ann Intern Med. 2001 Apr 17;134(8):663-94
11304107
J Gerontol A Biol Sci Med Sci. 1996 Jan;51(1):M37-43
8548512
Arthritis Rheum. 1991 May;34(5):505-14
2025304
Gerontology. 2008;54(2):106-15
18259094
J Am Geriatr Soc. 2005 Apr;53(4):695-9
15817019
Brain. 2000 Sep;123 ( Pt 9):1767-83
10960043
BMJ. 2007 Jan 13;334(7584):82
17158580
J Psychiatr Res. 1982-1983;17(1):37-49
7183759
Gait Posture. 2002 Aug;16(1):1-14
12127181
Psychopharmacol Bull. 1988;24(4):709-11
3249773
Phys Ther. 2008 Apr;88(4):449-59
18218822
Phys Ther. 2008 Dec;88(12):1482-91
18820094
Gait Posture. 2005 Feb;21(2):178-85
15639397
Clin Neuropharmacol. 2007 Mar-Apr;30(2):63-71
17414938
J Am Geriatr Soc. 2008 May;56(5):946-7
18454755
Arch Neurol. 2001 Dec;58(12):1985-92
11735772
J Gerontol. 1991 May;46(3):M69-76
2030269
Arch Neurol. 2004 Dec;61(12):1852-6
15596605
Brain. 1994 Aug;117 ( Pt 4):715-28
7922459
Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001190
16437430
Curr Opin Neurol. 2002 Aug;15(4):401-7
12151835
J Intern Med. 2004 Sep;256(3):240-6
15324367
Exp Brain Res. 2005 Aug;164(4):541-8
15864565