期刊
JOURNAL OF ALZHEIMERS DISEASE
卷 64, 期 2, 页码 597-606出版社
IOS PRESS
DOI: 10.3233/JAD-180121
关键词
Alzheimer's disease; deep brain stimulation; dementia; delayed start; fornix; treatment
资金
- National Institute on Aging [R01AG042165]
- Federal Economic Development Agency for Southern Ontario
- Functional Neuromodulation Ltd.
- ADvance study
- National Institutes of Health, Federal Economic Development Agency for Southern Ontario, Functional Neuromodulation
- NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE [R01NS096008] Funding Source: NIH RePORTER
- NATIONAL INSTITUTE OF NURSING RESEARCH [R01NR014852] Funding Source: NIH RePORTER
- NATIONAL INSTITUTE ON AGING [P50AG005146] Funding Source: NIH RePORTER
Background: Given recent challenges in developing new treatments for Alzheimer dementia (AD), it is vital to explore alternate treatment targets, such as neuromodulation for circuit dysfunction. We previously reported an exploratory Phase IIb double-blind trial of deep brain stimulation targeting the fornix (DBS-f) in mild AD (the ADvance trial). We reported safety but no clinical benefits of DBS-f versus the delayed-on (sham) treatment in 42 participants after one year. However, secondary post hoc analyses of the one-year data suggested a possible DBS-f benefit for participants >= 65 years. Objective: To examine the long-term safety and clinical effects of sustained and delayed-on DBS-f treatment of mild AD after two years. Methods: 42 participants underwent implantation of DBS-f electrodes, with half randomized to active DBS-f stimulation (early on) for two years and half to delayed-on (sham) stimulation after 1 year to provide 1 year of active DBS-f stimulation (delayed on). We evaluated safety and clinical outcomes over the two years of the trial. Results: DBS-f had a favorable safety profile with similar rates of adverse events across both trial phases (years 1 and 2) and between treatment arms. There were no differences between treatment arms on any primary clinical outcomes. However, post-hoc age group analyses suggested a possible benefit among older (>65) participants. Conclusion: DBS-f was safe. Additional study of mechanisms of action and methods for titrating stimulation parameters will be needed to determine if DBS has potential as an AD treatment. Future efficacy studies should focus on patients over age 65.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据