Deep Brain Stimulation for Alzheimer's Disease

July 15, 2020 updated by: Buddhist Tzu Chi General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hualien City, Taiwan, 970
        • Recruiting
        • Buddhist Tzu Chi General Hospital
        • Contact:
          • Shin Yuan Chen, MD
        • Principal Investigator:
          • Shin Yuan Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD with DBS
Alzheimer's disease subjects with optimal medication therapy and with DBS treatment
Device: Deep brain stimulation
Brain stimulation electrodes at parameters 2.0~4.5 V；60 μs；20 Hz
Other Names:
  • Deep brain stimulation electrodes (Medtronic or Abbott)
Drug: Best 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
Other Names:
  • Exelon (Rivastigmine Tartrate), Witgen (Memantine)
Active Comparator: AD without DBS
Alzheimer's disease subjects with optimal medication therapy and without DBS treatment
Drug: Best 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
Other Names:
  • Exelon (Rivastigmine Tartrate), Witgen (Memantine)
No Intervention: Normal control
Matched aged and demographics subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
Time Frame: 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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Collaborators

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Shin-Yuan Chen, MD., Buddhist Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2020

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB106-68-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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