Journal
ALZHEIMERS & DEMENTIA
Volume 13, Issue 10, Pages 1098-1106Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jalz.2017.02.005
Keywords
Alzheimer; Clinical meaningfulness; ADAS-Cog; Goal Attainment Scaling; Function; Clinical trial; Dementia; Cholinesterase inhibitor; Donepezil; Galantamine
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Funding
- Pfizer Canada
- Janssen-Ortho Inc
- Canadian Institutes of Health Research, through a CIHR Rx & D operating grant [DCT-49981]
- Dalhousie Medical Research Foundation as the Kathryn Allen Weldon Professor of Alzheimer Research
- National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP)
- Atlantic Canada Opportunities Agency (ACOA)
- Innovacorp.
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Introduction: The clinical meaningfulness of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) subscale change is disputed. We compared 2-to 4-point ADAS-Cog changes with changes in Goal Attainment Scaling (GAS) and everyday function across initial ADAS-Cog scores and treatment responses. Methods: This exploratory analysis evaluated mild-moderate Alzheimer's disease patients treated with donepezil (12 months) or galantamine (8 months). Clinical meaningfulness was defined as concomitant ADAS-Cog and GAS changes of 63 points and/or functional improvement. Results: Patients with >= 3-point ADAS-Cog improvement significantly improved on GAS but not on standard tests of everyday function. ADAS-Cog no change (<=+/- 63 points) was seen with mean GAS improvement. Initial ADAS-Cog improvement made endpoint improvement (ADAS-Cog 3 points and GAS 1 point) more likely (odds ratio = 6.9; 95% confidence interval = 2.5-19.5). In contrast, initial deterioration made endpoint improvement unlikely (0.33; 0.14-0.64). Discussion: ADAS-Cog improvement and no change were each associated with GAS improvement. Initial ADAS-Cog worsening was unlikely to result in later improvement. (C) 2017 Published by Elsevier Inc. on behalf of the Alzheimer's Association.
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