Deep Brain Stimulation for Alzheimer's Disease

Buddhist Tzu Chi General Hospital

Status: Unknown

Conditions: Alzheimer Disease; Deep Brain Stimulation; Dementia, Alzheimer Type

Treatments: Device: Deep brain stimulation; Drug: Best medical treatment for Alzheimer's disease

Study type: Interventional

Funder types: Other

Identifiers

NCT03959124

IRB106-68-A

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

AD with DBS

Experimental group

Description:

Alzheimer's disease subjects with optimal medication therapy and with DBS treatment

Treatment:

Device: Deep brain stimulation

Drug: Best medical treatment for Alzheimer's disease

AD without DBS

Active Comparator group

Description:

Alzheimer's disease subjects with optimal medication therapy and without DBS treatment

Treatment:

Drug: Best medical treatment for Alzheimer's disease

Normal control

No Intervention group

Description:

Matched aged and demographics subjects