Functional Outcomes of a Comprehensive, Individualized, Person‐Centered Management Program in Advanced Alzheimer’s Disease(AD): Results from a 52‐Week Randomized Controlled Trial

Abstract Background We conducted a 28‐week, single‐blind, randomized, controlled trial of the efficacy of Comprehensive, Individualized, Person‐Centered Management (CI‐PCM) and memantine treatment (Reisberg et al., Dement Geriatr Cogn Disord , 2017) in advanced AD persons. CI‐PCM and memantine was approximately 7.5 times more beneficial to AD persons on the Functional Assessment Staging Tool (FAST) (Kenowsky et. al., Alzheimer’s and Dementia , 2017) than to AD persons who received memantine alone in the memantine FDA approval pivotal trial conducted by Reisberg et. al., ( NEJM 2003). We also conducted a 24‐week extension study. Herein, we report the difference in functional outcomes between the CI‐PCM and Usual Community Care (UCC+FC) groups at 52‐weeks on the FAST and the ADCS‐ADL Sev‐Abv. See Figures 1 and 2. Method After screening, 20 eligible subject‐carepartner dyads were randomized equally to the CI‐PCM and UCC+FC groups. All 20 dyads completed the 28‐week study and entered the 24‐week extension study. One subject in the UCC+FC group died during the extension study. The FAST and ADCS‐ADL sev‐abv were conducted at baseline, and weeks 4, 12, 28, and 52. P values were calculated using the Wilcoxon Mann Whitney test. Result The mean FAST total score from baseline (6.6±0.1SE) to week 52 (6.5±0.01SE) showed an improvement of functional limitations in the CI‐PCM group. The mean FAST total score for the UCC+FC group showed a functional decline from baseline (6.6±0.1SE) to week 52 (6.8±0.1SE), displaying a robustly significant difference between the two groups (p<0.0014). The mean ADCS‐ADL‐ sev‐abv total score for the CI‐PCM group demonstrated a 20.9% improvement in functioning from baseline (15.3±2.0SE) to week 52 (18.5±2.5SE). The mean ADCS‐ADL‐ sev‐abv total score for the UCC+FC group showed a decline of 48.6% from baseline (14.8±2.1SE) to week 52 (7.6±2.3SE), indicating a significant difference between the two groups (p<0.009). Conclusion The CI‐PCM program is the only evidenced‐based treatment to date that can significantly improve and reverse functional deterioration in advanced AD persons. The functional success of the CI‐PCM program may primarily be attributed to care partners learning to memory coach AD persons to perform daily activities such as bathing, dressing, feeding and toileting themselves, and to become/maintain urinary and fecal continence.