Deep Brain Stimulation for Alzheimer's Disease

Buddhist Tzu Chi General Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

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.

Time frame: One year

Deep Brain Stimulation for Alzheimer's Disease

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts