Effect of Age on Clinical Trial Outcome in Participants with Probable Alzheimer’s Disease

Autor: Anna D. Burke, Kristen E. Drake, Lisa Fosdick, Steven D. Targum, Gwenn S. Smith, Constantine G. Lyketsos, Marwan N. Sabbagh, Paul B. Rosenberg, Wael F. Asaad, Kelly D. Foote, Andres M. Lozano, David A. Wolk
Rok vydání: 2021
Předmět:
Zdroj: Journal of Alzheimer's Disease
ISSN: 1875-8908
1387-2877
Popis: Background: Age may affect treatment outcome in trials of mild probable Alzheimer’s disease (AD). Objective: We examined age as a moderator of outcome in an exploratory study of deep brain stimulation targeting the fornix (DBS-f) region in participants with AD. Methods: Forty-two participants were implanted with DBS electrodes and randomized to double-blind DBS-f stimulation (“on”) or sham DBS-f (“off”) for 12 months. Results: The intervention was safe and well tolerated. However, the selected clinical measures did not differentiate between the “on” and “off” groups in the intent to treat (ITT) population. There was a significant age by time interaction with the Alzheimer’s Disease Assessment Scale; ADAS-cog-13 (p = 0.028). Six of the 12 enrolled participants
Databáze: OpenAIRE