Alzheimer Disease, Deep Brain Stimulation, Dementia, Alzheimer Type
Conditions
Keywords
magnetic resonance image
Brief summary
Background: Deep brain stimulation (DBS) is used to modulate the activity of dysfunctional brain circuits. The safety and preliminary efficacy of nucleus basalis of Meynert (NBM)-DBS in Alzheimer's disease (AD) is proved in a recent phase 1 clinical trial, yet, the mechanism still unknown. Objective: 1. To compare the brain structure and functional circuits between a) AD patients with optimal drug treatment (ODT) plus NBM-DBS, b) AD with ODT and c) normal age-and sex-matched control. 2. To evaluate the clinical effectiveness of NBM-DBS in AD patients 60-75 year-old. 3. To evaluate the abnormal functional circuitry response to acute and chronic NBM-DBS in AD. Methods: A total of 30 subjects (10 subjects of AD with ODT plus NBM-DBS; 10 subjects of AD with ODT and 10 subjects of normal age-and sex-matched subjects) will be enrolled in this prospective, with normal control, Phase II study. Study tools will include clinical rating batteries, structure and functional imaging of magnetic resonance (MR) and positron emission tomography (PET), and electroencephalogram (EEG). Expected Results: NBM-DBS will be proved to be an safe and effective treatment modality in AD patients 60-75 year-old. Through multi-modal images and EEG analysis, the possible action mechanisms of NBM-DBS on memory circuit will be discussed. The study results may shed a light on this helpless neurodegenerative disease of dementia.
Interventions
DEVICEDeep brain stimulation
Brain stimulation electrodes at parameters 2.0\ 4.5 V；60 μs；20 Hz
DRUGBest medical treatment for Alzheimer's disease
Alzheimer's disease patients take medications including Exelon (Rivastigmine Tartrate), Witgen (Memantine) for at least 3 months without plan of dosage adjustment
Sponsors
Beijing Tiantan Hospital
Buddhist Tzu Chi General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
For groups (AD with/ without DBS) 1. Confirmed Alzheimer's dementia diagnosis 2. Regular medications taking for at least 3 months 3. Clinical Dementia Rating: 0.5 - 2 4. Mini Mental Status Examination: ≦ 26 5. Amyloid PET: positive 6. Informed consent signed by patients or families For normal control group 1. No cognitive impairment (Mini Mental Status Examination) 2. Amyloid PET: negative 3. Informed consent signed by patients and families
Exclusion criteria
For groups (AD with/ without DBS) 1. Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery) 2. Other neurodegenerative/ neuropsychiatric diseases 3. Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease) 4. Can't have regular follow-up visit For normal control group 1. Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery) 2. Dementia/ neurodegenerative/ neuropsychiatric diseases 3. Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease) 4. Can't have regular follow-up visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) | One year | Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale; Total scores range from 0-70. Higher scores (≥ 18) indicate worse cognitive function. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities. |
Countries
Taiwan
Contacts
Primary ContactShin-Yuan Chen, MD.
Backup ContactTing-Wen Hou, BS.
Outcome results
None listed