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 |
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Rok vydání: | 2021 |
Předmět: |
Male
0301 basic medicine Aging medicine.medical_specialty Deep brain stimulation Deep Brain Stimulation medicine.medical_treatment Population subject selection Disease Affect (psychology) 03 medical and health sciences Age 0302 clinical medicine Double-Blind Method Alzheimer Disease Rating scale Internal medicine medicine Humans education Aged Aged 80 and over clinical trials education.field_of_study Intention-to-treat analysis business.industry General Neuroscience General Medicine Middle Aged Electrodes Implanted Clinical trial Psychiatry and Mental health Clinical Psychology Treatment Outcome 030104 developmental biology Biomarker (medicine) Female Geriatrics and Gerontology business Alzheimer’s disease 030217 neurology & neurosurgery Research Article |
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 |
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