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Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial.
Neurology. 2009 May 05; 72(18):1555-61.Neur

Abstract

BACKGROUND

Treatment of mild cognitive impairment (MCI) with cholinesterase inhibitors may improve symptoms.

METHODS

In this multicenter, randomized, placebo-controlled trial, subjects with MCI entered a 3-week placebo run-in period followed by 48 weeks of double-blind donepezil (5 mg/day for 6 weeks, then 10 mg/day for 42 weeks) or placebo treatment. Primary efficacy variables included change from baseline in the modified Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Clinical Dementia Rating Scale-sum of boxes (CDR-SB) after 48 weeks of treatment (modified intention-to-treat analysis). Secondary efficacy measures evaluated cognition, behavior, and function.

RESULTS

The dual primary efficacy endpoint was not reached. We noted a small, but significant, decrease in modified ADAS-Cog scores in favor of donepezil at study endpoint. Little change from baseline in CDR-SB and secondary variables was observed for either group. Patient Global Assessment scores favored donepezil at all time points except week 12 (p < or = 0.05). Perceived Deficits Questionnaire scores favored donepezil at week 24 (p = 0.05). Clinical Global Impression of Change-MCI scores favored donepezil only at week 6 (p = 0.04). Adverse events were generally mild or moderate. More donepezil-treated subjects (18.4%) discontinued treatment due to adverse events than placebo-treated subjects (8.3%).

CONCLUSIONS

Donepezil demonstrated small but significant improvement on the primary measure of cognition but there was no change on the primary measure of global function. Most other measures of global impairment, cognition, and function were not improved, possibly because these measures are insensitive to change in MCI. Responses on subjective measures suggest subjects perceived benefits with donepezil treatment.

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Authors+Show Affiliations

Doody RS
Alzheimer's Disease and Memory Disorders Center, Baylor College of Medicine, 6550 Fannin, Suite 1801, Houston, TX 77030, USA.
Ferris SH
No affiliation info available
Salloway S
No affiliation info available
Sun Y
No affiliation info available
Goldman R
No affiliation info available
Watkins WE
No affiliation info available
Xu Y
No affiliation info available
Murthy AK
No affiliation info available

MeSH

AgedAged, 80 and overAlzheimer DiseaseCholinesterase InhibitorsCognition DisordersDisease ProgressionDonepezilDouble-Blind MethodEndpoint DeterminationFemaleHumansIndansMaleMiddle AgedNeuropsychological TestsOutcome Assessment, Health CarePatient CompliancePiperidinesSeverity of Illness IndexTreatment Outcome

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19176895

Clinical Trial Links

Memantine Plus Es-citalopram in Elderly Depressed Patients With Cognitive Impairment

Citation

Doody, R S., et al. "Donepezil Treatment of Patients With MCI: a 48-week Randomized, Placebo-controlled Trial." Neurology, vol. 72, no. 18, 2009, pp. 1555-61.
Doody RS, Ferris SH, Salloway S, et al. Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial. Neurology. 2009;72(18):1555-61.
Doody, R. S., Ferris, S. H., Salloway, S., Sun, Y., Goldman, R., Watkins, W. E., Xu, Y., & Murthy, A. K. (2009). Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial. Neurology, 72(18), 1555-61. https://doi.org/10.1212/01.wnl.0000344650.95823.03
Doody RS, et al. Donepezil Treatment of Patients With MCI: a 48-week Randomized, Placebo-controlled Trial. Neurology. 2009 May 5;72(18):1555-61. PubMed PMID: 19176895.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Donepezil treatment of patients with MCI: a 48-week randomized, placebo-controlled trial. AU - Doody,R S, AU - Ferris,S H, AU - Salloway,S, AU - Sun,Y, AU - Goldman,R, AU - Watkins,W E, AU - Xu,Y, AU - Murthy,A K, Y1 - 2009/01/28/ PY - 2009/1/30/entrez PY - 2009/1/30/pubmed PY - 2009/7/1/medline SP - 1555 EP - 61 JF - Neurology JO - Neurology VL - 72 IS - 18 N2 - BACKGROUND: Treatment of mild cognitive impairment (MCI) with cholinesterase inhibitors may improve symptoms. METHODS: In this multicenter, randomized, placebo-controlled trial, subjects with MCI entered a 3-week placebo run-in period followed by 48 weeks of double-blind donepezil (5 mg/day for 6 weeks, then 10 mg/day for 42 weeks) or placebo treatment. Primary efficacy variables included change from baseline in the modified Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Clinical Dementia Rating Scale-sum of boxes (CDR-SB) after 48 weeks of treatment (modified intention-to-treat analysis). Secondary efficacy measures evaluated cognition, behavior, and function. RESULTS: The dual primary efficacy endpoint was not reached. We noted a small, but significant, decrease in modified ADAS-Cog scores in favor of donepezil at study endpoint. Little change from baseline in CDR-SB and secondary variables was observed for either group. Patient Global Assessment scores favored donepezil at all time points except week 12 (p < or = 0.05). Perceived Deficits Questionnaire scores favored donepezil at week 24 (p = 0.05). Clinical Global Impression of Change-MCI scores favored donepezil only at week 6 (p = 0.04). Adverse events were generally mild or moderate. More donepezil-treated subjects (18.4%) discontinued treatment due to adverse events than placebo-treated subjects (8.3%). CONCLUSIONS: Donepezil demonstrated small but significant improvement on the primary measure of cognition but there was no change on the primary measure of global function. Most other measures of global impairment, cognition, and function were not improved, possibly because these measures are insensitive to change in MCI. Responses on subjective measures suggest subjects perceived benefits with donepezil treatment. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/19176895/Donepezil_treatment_of_patients_with_MCI:_a_48_week_randomized_placebo_controlled_trial_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&amp;pmid=19176895 DB - PRIME DP - Unbound Medicine ER -