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P3‐392: EFFECT OF A POSITIVE INTERACTION, GROUP‐BASED ACTIVITY PROGRAM (PIGAP) FOR DEMENTIA PATIENTS AND CAREGIVERS
Author(s) -
Hwang Yun Jung,
Jeong WonMee,
Youn JongChul,
Lee Dong Young,
Woo Jong Inn
Publication year - 2014
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.2014.05.1486
Subject(s) - loneliness , ucla loneliness scale , sss* , psychosocial , dementia , psychology , clinical psychology , clinical dementia rating , medicine , gerontology , psychiatry , disease
capsule containing 28-mg memantine extended release (ER) and 10-mg donepezil was developed and tested for (1) bioequivalence with co-administered commercially available memantine ER (Namenda XR, 28 mg) and donepezil (Aricept, 10 mg), (2) bioavailability following food intake, and (3) bioavailability following sprinkling of the capsule contents on applesauce. Methods: Both studies were single-dose, randomized, open-label, and crossover (with 21-day washout periods between treatments), conducted in 18-45-year-old healthy individuals. In Study 1, fasting participants (N1⁄438) received Treatment A (co-administration of Namenda XR and Aricept) or Treatment B (FDC). In Study 2, participants (N1⁄436) received three treatments: Treatment A (intact FDC capsule, while fasting), Treatment B (intact FDC capsule, following a high-fat meal), and Treatment C (FDC contents sprinkled on applesauce, while fasting). In both studies, C max and AUC 0ˆ z for memantine and donepezil were compared using a linear mixed-effects model. Bioequivalence or no effect in the comparison of treatments was declared if the 90% confidence intervals (CI) of the least-squares geometric mean ratios of C max and AUC 0ˆ z were within the range of 80.00%-125.00%. T max values were compared using a Wilcoxon signed-rank test. Safety parameters were also evaluated. Results: CIs of all the comparisons were within 80.00%-125.00% window. The FDC capsule containing memantine ER and donepezil was bioequivalent to co-administered Namenda XR and Aricept. There was no significant food effect on the bioavailability of the FDC capsule. The intact FDC capsule and capsule contents sprinkled on applesauce were bioequivalent. There were no clinically relevant differences in T max across treatments. Safety profiles were also similar across treatments. Conclusions: A FDC capsule containing 28-mg memantine ER and 10-mg donepezil is bioequivalent to co-administered commercially available memantine ER and donepezil. In addition to ingestion by swallowing with or without food, the formulation allows for sprinkling of the capsule contents on applesauce, making ingestion and administration easier for patients and caregivers, respectively. Sponsorship: Forest Research Institute.