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Alzheimers Dement. 2017 Oct;13(10):1098-1106. doi: 10.1016/j.jalz.2017.02.005. Epub 2017 Mar 21.

Clinical meaningfulness of Alzheimer's Disease Assessment Scale-Cognitive subscale change in relation to goal attainment in patients on cholinesterase inhibitors.

Author information

1
DGI Clinical Inc., Halifax, Nova Scotia, Canada; Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: krockwood@dgiclinical.com.
2
Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Pharmacology, Dalhousie University, Halifax, Nova Scotia, Canada.
3
Pfizer Global Outcomes Research, New London, Connecticut, USA.
4
DGI Clinical Inc., Halifax, Nova Scotia, Canada; Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

Abstract

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 ±3 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" (≤±3 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.

CLINICAL TRIAL REGISTRATION NUMBER:

ISRCTN26167328.

KEYWORDS:

ADAS-Cog; Alzheimer; Cholinesterase inhibitor; Clinical meaningfulness; Clinical trial; Dementia; Donepezil; Function; Galantamine; Goal Attainment Scaling

PMID:
28341540
DOI:
10.1016/j.jalz.2017.02.005
[Indexed for MEDLINE]

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