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


CONCLUSIONS
ADAS-Cog improvement and no change were each associated with GAS improvement. Initial ADAS-Cog worsening was unlikely to result in later improvement.


BACKGROUND
ISRCTN26167328.
DGI Clinical Inc., Halifax, Nova Scotia, Canada; Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: krockwood@dgiclinical.com.
Kenneth
K
Rockwood
Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; Department of Pharmacology, Dalhousie University, Halifax, Nova Scotia, Canada.
Susan E
SE
Howlett
Pfizer Global Outcomes Research, New London, Connecticut, USA.
Deborah
D
Hoffman
Pfizer Global Outcomes Research, New London, Connecticut, USA.
Rachel
R
Schindler
DGI Clinical Inc., Halifax, Nova Scotia, Canada; Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
Arnold
A
Mitnitski
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D002170:Canada; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D003072:Cognition Disorders / Q000145:classification / Q000188:drug therapy / Q000209:etiology; D000077265:Donepezil; D004311:Double-Blind Method; D005260:Female; D005702:Galantamine / Q000627:therapeutic use; D006040:Goals; D006801:Humans; D007189:Indans / Q000627:therapeutic use; D008297:Male; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care; D010880:Piperidines / Q000627:therapeutic use; D012720:Severity of Illness Index
D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D005702:Galantamine; D000077265:Donepezil
ADAS-Cog; Alzheimer; Cholinesterase inhibitor; Clinical meaningfulness; Clinical trial; Dementia; Donepezil; Function; Galantamine; Goal Attainment Scaling