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Deep Brain Stimulation for Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03959124
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Buddhist Tzu Chi General Hospital

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia, Alzheimer Type Deep Brain Stimulation Device: Deep brain stimulation Drug: Best medical treatment for Alzheimer's disease Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Deep Brain Stimulation on Memory Network and Neurological Function of Alzheimer's Disease
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Exelon (Rivastigmine Tartrate), Witgen (Memantine)

No Intervention: Normal control
Matched aged and demographics subjects



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For groups (AD with/ without DBS)

  1. Right handed
  2. Confirmed Alzheimer's dementia diagnosis
  3. Regular medications taking for at least 3 months
  4. Clinical Dementia Rating: 0.5 - 1
  5. Mini Mental Status Examination: 18 - 26
  6. Amyloid PET: positive
  7. Informed consent signed by patients or families

For normal control group

  1. Right handed
  2. No cognitive impairment (Mini Mental Status Examination)
  3. Amyloid PET: negative
  4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959124


Contacts
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Contact: Shin-Yuan Chen, MD. +886-3-8561825 ext 12151 william.sychen@msa.hinet.net
Contact: Ting-Wen Hou, BS. +886-3-8561825 ext 12151 tcpdcenter@gmail.com

Locations
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Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien City, Taiwan, 970
Contact: Shin Yuan Chen, MD         
Principal Investigator: Shin Yuan Chen, MD         
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Shin-Yuan Chen, MD. Buddhist Tzu Chi General Hospital

Publications:

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Responsible Party: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03959124     History of Changes
Other Study ID Numbers: IRB106-68-A
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Buddhist Tzu Chi General Hospital:
magnetic resonance image

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
Rivastigmine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents