Premium
P3‐004: MUSIC INTERVENTION FOR PEOPLE WITH DEMENTIA USING A DYADIC APPROACH: CLINICAL EXPERIENCE TO SHAPE A CLINICAL TRIAL
Author(s) -
Karstens Aimee J.,
Hospelhorn Emma,
Wolfe Jeffrey,
Ziemba Amanda,
Morson Emily,
Wise Peggy,
Crown Rickie,
Rook Jenni,
Bonakdarpour Borna
Publication year - 2018
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.2018.06.1359
Subject(s) - affect (linguistics) , psychology , dyad , dementia , intervention (counseling) , music therapy , psychological intervention , clinical psychology , developmental psychology , medicine , psychotherapist , psychiatry , communication , disease , pathology
Alzheimer’s disease can be used to identify a group of patients with mild to moderate AD with more significant and consistent decline on placebo treatment over 6 months. Methods: Data were pooled from three 24-week, randomized, double-blind, placebo-controlled studies in mild to moderate AD (Atri et al 2018). The studies included men and women aged 50 years with probable AD and a Mini–Mental State Examination (MMSE) score of 12–22, who had received a Cholinesterase inhibitor for 4 months prior to screening. Key outcome measures were (1) The Alzheimer’s Disease Assessment Scale – Cognitive subscale (ADAS-Cog; a measure of cognition). (2) Alzheimer’s Disease Cooperative Study – Activities of Daily Living, 23-item version (ADCS-ADL). (3) The Alzheimer’s Disease Cooperative Study – Clinical Global Impression of Change (ADCS-CGIC). (4) Neuropsychiatric Inventory (NPI) was a secondary outcome to assess behavioral disturbances. Results:A total of 963 patients were randomized to placebo Patients with amyloid positivity had a greater decline on ADAS-Cog (mean difference: 1.51; 95% confidence interval 0.13, 2.90; p1⁄40.032) and ADCS-CGIC (0.33; 0.08, 0.57; p1⁄40.0086). ApoE-ε4 homozygotes had a greater decline on ADCS-ADL23 (-1.88; -3.60, -0.15; p1⁄40.033), ADCS-CGIC (0.24; 0.00, 0.47; p1⁄40.049), and NPI (3.68; 1.59, 5.77; p1⁄40.0006). Patients with a first-degree relative with AD had a greater decline on ADAS-Cog (1.12; 0.25, 1.99; p1⁄40.012). A merged enrichment group was identified by pooling individuals fulfilling at least one of the individual enrichment criteria. This broader enrichment group continued to identify individuals with greater decline/worsening on ADAS-Cog (1.46; 0.63, 2.30; p1⁄40.0006) and NPI (2.12; 0.77, 3.47; p1⁄40.0021). This approach substantially increased power to identify a difference of 25% between treatment groups, for example achieving a power of 75% to p<0.05 with less than 100 participants per group for individuals who were amyloid positive. Conclusions: Even in symptomatic treatment trials over 6 months enrichment is critical and can play a crucial role in designing studies with a substantially better chance of identifying any positive treatment effects.