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P3–276: Long‐acting intranasal insulin detemir improves working memory for adults with mild cognitive impairment or early‐stage Alzheimer's dementia
Author(s) -
Claxton Amy,
Baker Laura,
Hanson Angela,
Cholerton Brenna,
Trittschuh Emily,
Morgan Amy,
Callaghan Maureen,
Arbuckle Matthew,
Behl Colin,
Craft Suzanne
Publication year - 2013
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2013.05.1350
Subject(s) - insulin detemir , dementia , working memory , audiology , insulin , placebo , psychology , medicine , effects of sleep deprivation on cognitive performance , cognition , psychiatry , disease , hypoglycemia , alternative medicine , pathology , insulin glargine
Background: The OPTIMA study (NCT00506415) demonstrated reduced deterioration with 13.3 (15cm 2) versus 9.5 mg/24h (10cm 2) rivastigmine patch in patients with Alzheimer’s disease (AD). Treatment response can vary according to patients’ individual characteristics. We conducted a responder analysis to identify the proportion of patients demonstrating a treatment response to each dose, and patient characteristics predictive of achieving a response. Methods: Details of OPTIMA are published (Cummings et al, 2012). Patients meeting prespecified decline criteria during treatment with 9.5 mg/24h patch, entered a 48-week, double-blind (DB) phase, and were randomized to 13.3 or 9.5 mg/24h. The AD Assessment Scale-cognitive subscale (ADAS-cog) and AD Cooperative Study-Instrumental Activities of Daily Living scale (ADCS-IADL) were co-primary endpoints. In this post-hoc analysis, the following criteria for achieving a treatment response were applied: 4 points’ improvement on ADAS-cog, and 4 points’ improvement on ADAS-cog combined with no decline on ADCS-IADL. The proportion of patients meeting these criteria in each treatment group was assessed at Weeks 24 and 48. Further analyses were conducted with additional response criteria, applied to reflect the unique study design with an active comparator (13.3 versus 9.5 mg/24h) in a declining population. These include 4 points’ decline in both ADAS-cog and ADCS-IADL. Analyses of possible predictors of response, using stepwise logistic regression, are underway and will be presented. Results: Demographics and baseline scores were comparable between patient groups (13.3 mg/24h, N1⁄4265; 9.5 mg/ 24h, N1⁄4271). For all responder criteria, a greater proportion of patients achieved a treatment response with 13.3 versus 9.5 mg/24h patch. At Week 24, 25 versus 14% (p1⁄40.001) of patients receiving 13.3 and 9.5 mg/24h patch, respectively, demonstrated 4 points’ improvement on ADAS-cog, and 17 versus 7% (p<0.001) demonstrated 4 points’ improvement on ADAS-cog and no decline on ADCS-IADL. Of patients receiving 13.3 and 9.5 mg/24h patch, respectively, at Week 48, 16% and 10% (p1⁄40.020) displayed 4 points’ improvement on ADAS-cog, and 8% versus 4% (p1⁄40.023) demonstrated 4 points’ improvement on ADAS-cog and no decline on ADCS-IADL. Conclusions: Titration of patients with mild-to-moderate AD to the high-dose (13.3 mg/24h) rivastigmine patch (15cm 2) increases the likelihood of achieving a clinically meaningful treatment response.