Cognitive Brain Aging Reversal From Deep Brain Stimulation for Alzheimer's Dementia: a Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Dementia Rating Scales
研究概览
简要总结
The purpose of this study is to test a new procedure to treat Alzheimer's disease. The procedure is called intermittent Deep Brain Stimulation (DBS) of the nucleus basalis of Meynert. There will be up to six participants enrolled at Wellstar MCG Memory Clinic. There will be another six participants similarly enrolled to act as a control group that does not receive DBS. This second group will document the course of progression of Alzheimer's disease under the normal standard of care. The main goal of the study is to determine if DBS can sustain or improve cognition in Alzheimer's disease for at least two years. Participant data, with identifying information removed, may be shared with online repositories for comparison with trials with similar subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:65 minimum
- •Age:85 maximum
- •Probable, early-stage Alzheimer's Disease, as defined by NIA-AA 2018 criteria and positive PET for beta amyloid,
- •no Lewy-Body-dementia or other form of dementia
- •Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a CBR-sb score from 2 to
- •MMSE ≥ 21
- •stable psychopharmacological medication equivalent to 10 mg/day donepezil or less for at least 60 days
- •valid informed consent
- •an available caregiver willing to participate
- •subject is living at home and likely to remain at home for the study duration
- •Geriatric Depression Scale of 5 or less
- •Columbia Suicide Severity Rating Scale "No" on questions 3 through 5
- •Neuropsychiatric Inventory (NPI-Q) under 2 on 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales
排除标准
- •• clinical co-morbidity interfering with study (e.g. head trauma requiring medical treatment in the 2 years prior, brain tumor, subdural hematoma, or other clinically significant space-occupying lesion on brain CT or MRI), or other implant precluding high field MRI scans.
- •current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit, or past medical history prior suicidal attempts or suicidal crises
- •Another concurrent CNS condition (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology).
- •Medical history of seizure disorder including epilepsy
- •Terminal illness associated with expected survival of <30 months
- •Subjects with one of these other forms of dementia in the DSM-5 heading of Neurocognitive Disorders: Lewy body disease, Frontotemporal lobar degeneration, Vascular disease, Traumatic brain injury, HIV infection, Prion disease, Parkinson's disease, Huntington's disease, or due to multiple etiologies
- •Subjects with unstable medical and neurological conditions at the discretion of the Principle Investigator
研究组 & 干预措施
Intermittent deep brain stimulation of the nucleus basalis of Meynert
Subjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day. Assessments will be performed at onset, after four weeks of intervention, and each six months through two years.
干预措施: Intermittent deep brain stimulation of the nucleus basalis of Meynert (Device)
Control group
Subjects will have matching eligility criteria as those in the experimental arm, but will receive no intervention. Assessments will be performed at study onset, and each six months through two years after onset.
结局指标
主要结局
Dementia Rating Scales
时间窗: Two years after intervention onset
Subjects will be evaluated using the Clinical Dementia Rating Sum of Boxes scale. The investigators seeks for half of the intervention arm participants to have better (lower) or equal scale scores two years after intervention onset than they had at onset. This scale ranges from 0 to 18, and subjects will score from 2 to 6 at study entry.
Alzheimer's Disease Assessment Scale, Cognitive Subscale
时间窗: Two years of intervention
The investigators seeks for scores on the Alzheimer's Disease Assessment Scale, Cognitive Subscale, to be equal or lower in half of the participants two years after the intervention begins compared to their value at study onset. This scale ranges from 0 to 85, and subjects at onset will likely have scores between 13 and 30.
次要结局
- PET scans for beta amyloid(Two years after study onset.)
- Anxiety scales(Two years of intervention)
- Beta amyloid PET imaging, Centiloid scale.(Two years of intervention)
- PHQ-9 questionaire(Two years of intervention)
研究者
David Blake
Professor David T. Blake
Augusta University