Kenneth Rockwood1, Susan E Howlett2, Deborah Hoffman3, Rachel Schindler3, Arnold Mitnitski4. 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.
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 diseasepatients 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.
Authors: Adam L Boxer; Michael Gold; Howard Feldman; Bradley F Boeve; Susan L-J Dickinson; Howard Fillit; Carole Ho; Robert Paul; Rodney Pearlman; Margaret Sutherland; Ajay Verma; Stephen P Arneric; Brian M Alexander; Bradford C Dickerson; Earl Ray Dorsey; Murray Grossman; Edward D Huey; Michael C Irizarry; William J Marks; Mario Masellis; Frances McFarland; Debra Niehoff; Chiadi U Onyike; Sabrina Paganoni; Michael A Panzara; Kenneth Rockwood; Jonathan D Rohrer; Howard Rosen; Robert N Schuck; Holly D Soares; Nadine Tatton Journal: Alzheimers Dement Date: 2020-01-06 Impact factor: 21.566
Authors: Kari Knox; Justin Stanley; James A Hendrix; Hampus Hillerstrom; Taylor Dunn; Jillian Achenbach; Brian A Chicoine; Florence Lai; Ira Lott; Sanja Stanojevic; Susan E Howlett; Kenneth Rockwood Journal: J Patient Rep Outcomes Date: 2021-01-11
Authors: Taylor Dunn; Susan E Howlett; Sanja Stanojevic; Aaqib Shehzad; Justin Stanley; Kenneth Rockwood Journal: J Med Internet Res Date: 2022-01-27 Impact factor: 5.428