Alzheimer Disease Clinical Trial
Official title:
The Effect of Deep Brain Stimulation on Memory Network and Neurological Function of Alzheimer's Disease
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.
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