NCT03622905已完成不适用
ADvance II: A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients With Mild Probable Alzheimer's Disease
Functional Neuromodulation Ltd35 个研究点 分布在 3 个国家目标入组 74 人开始时间: 2019年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 35
- 主要终点
- Change From Baseline Over Time at 12 months on the Ingegrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: From Baseline to month 12 ]
研究概览
简要总结
The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer's disease rating scale (iADRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the subject and caregiver.
- •At least 65 years old
- •Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
- •Mild dementia according to the Clinical Dementia Rating (CDR) global rating of 0.5 or 1 at screening.
- •ADAS-cog-11 score of 10-24 inclusive at screening AND baseline (with a score ≥ 4 on ADAS-cog item 1).
- •Confirmation of Alzheimer's disease based on CSF biomarkers.
- •The patient has an available caregiver or other appropriate knowledgeable informant who can reliably report on daily activities and function and signs the informed consent for participation as such.
- •Patient must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team.
- •Fluency (oral and written) in the language in which standardized tests will be administered.
- •The patient is either
- •taking a stable dose of cholinesterase inhibitor (AChEI) medication (donepezil, galantamine, or rivastigmine) for at least 60 days prior to signing the informed consent form OR
- •the patient has previously had an intolerance/failure to cholinesterase inhibitor medications that can be documented AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified during the 12-month control period).
- •c) a physician has fully discussed the possibility of prescribing cholinesterase inhibitors and the physician in collaboration with the patient/caregiver have declined trying cholinesterase inhibitors and this discussion and decision are fully documented in the patient's medical records. This discussion occurred during the course of the patient's care, and not as a component of enrollment or discussion of participation in this clinical trial.
- •AND there is no intention to modify the dose over the course of the study (NOTE: These medications may NOT be initiated, discontinued or modified after study initiation for the 12-months control period).
排除标准
- •NPI total score ≥ 10 or score ≥ 4 in any NPI domain (clinically significant neuropsychiatric symptoms). Apathy score ≥ 4 acceptable.
- •Modified Hachinski ischemia scale score > 4 at screening.
- •At risk for suicide in the opinion of the investigator or the subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at the time of evaluation) at the screening visit or attempted suicide within the last 2 years.
- •Suffers from a major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder, or has current alcohol or substance abuse based on psychiatric consultation at screening visit.
- •History of moderate or more severe traumatic brain injury in the 2 years prior to signing the consent to participate in the study.
- •History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI.
- •History of seizure disorder.
- •Contraindications for MRI scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
- •Radiation exposure in the 1 year prior to signing the informed consent form that, in combination with the radiation exposure from this study, would exceed 5 rem.
- •Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator would preclude participation in the study.
- •Currently prescribed or planning to start any amyloid-beta directed antibody drug (e.g. aducanumab or similar) within the first year following implantation in this study. Prior use of amyloid-beta directed antibody drugs must be stopped at least 6 months prior to signing consent.
- •Currently prescribed any non-AD medications that, in the opinion of the investigator would preclude participation in the study.
- •Is unable or unwilling to comply with protocol follow-up requirements.
- •Has a life expectancy of < 1 year.
- •Is actively enrolled in another concurrent clinical trial.
结局指标
主要结局
Change From Baseline Over Time at 12 months on the Ingegrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: From Baseline to month 12 ]
时间窗: 12 months
The iADRS is a composite tool that combines scores from the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL). It measures both cognition and function and demonstrates acceptable psychometric properties, and is effective in capturing both disease progression and separation of placebo and active treatment effect. The iADRS score ranges from 0 to 146 with lower scores indicating worse performance.
次要结局
- Change From Baseline Over Time at 12 months on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) [ Time Frame: From Baseline to month 12 ](12 months)
研究者
研究点 (35)
Loading locations...
相似试验
已完成
不适用
ADvance DBS-f in Patients With Mild Probable Alzheimer's DiseaseAlzheimer DiseaseNCT01608061Functional Neuromodulation Ltd42
已完成
不适用
Deep Brain Stimulation for Patients With Dementia With Lewy BodiesDementia With Lewy BodiesNCT02263937University College, London6
Unknown
不适用
Deep Brain Stimulation of Nucleus Accumbens for Methamphetamine AddictionTreatment Methamphetamine AddictionNCT03347474Ruijin Hospital10
已完成
2 期
Adipose Derived Stem Cells in Facial Fat GraftingFacial AtrophyNCT02526576Antria34
Unknown
不适用
Fornix and NbM as Targets of Stimulation In Alzheimer's DiseaseAlzheimer DiseaseNCT03352739Xuanwu Hospital, Beijing30