NCT05997030招募中不适用
Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ali Rezai
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Cognitive Change
研究概览
简要总结
This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.
详细描述
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant females, aged 45-85 years
- •Able and willing to give informed consent
- •Must meet the clinical criteria for MCI due to Alzheimer's disease
- •If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
- •Able to communicate sensations during the LIFU procedure
排除标准
- •Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
- •Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
- •Participants with a history of seizure disorder.
- •Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
- •Participant does not speak English
- •Participant is pregnant or planning to be pregnant
结局指标
主要结局
Cognitive Change
时间窗: baseline and 7 days after procedure
Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Occurrence of Treatment Emergent Adverse Events
时间窗: baseline and 7 and days after study procedure
Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
次要结局
- Imaging Changes(baseline, 7 and 30 days)
研究者
研究点 (2)
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