Deep Brain Stimulation for Alzheimer's Disease
The Effect of Deep Brain Stimulation on Memory Network and Neurological Function of Alzheimer's Disease
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJuly 17, 2020
June 1, 2020
6 months
February 21, 2019
July 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
One year
Study Arms (3)
AD with DBS
EXPERIMENTALAlzheimer's disease subjects with optimal medication therapy and with DBS treatment
AD without DBS
ACTIVE COMPARATORAlzheimer's disease subjects with optimal medication therapy and without DBS treatment
Normal control
NO INTERVENTIONMatched aged and demographics subjects
Interventions
Brain stimulation electrodes at parameters 2.0\~4.5 V；60 μs；20 Hz
Alzheimer's disease patients take medications including Exelon (Rivastigmine Tartrate), Witgen (Memantine) for at least 3 months without plan of dosage adjustment
Eligibility Criteria
You may qualify if:
- For groups (AD with/ without DBS)
- Confirmed Alzheimer's dementia diagnosis
- Regular medications taking for at least 3 months
- Clinical Dementia Rating: 0.5 - 2
- Mini Mental Status Examination: ≦ 26
- Amyloid PET: positive
- Informed consent signed by patients or families
- For normal control group
- No cognitive impairment (Mini Mental Status Examination)
- Amyloid PET: negative
- Informed consent signed by patients and families
You may not qualify if:
- For groups (AD with/ without DBS)
- Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery)
- Other neurodegenerative/ neuropsychiatric diseases
- Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease)
- Can't have regular follow-up visit
- For normal control group
- Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery)
- Dementia/ neurodegenerative/ neuropsychiatric diseases
- Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease)
- Can't have regular follow-up visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Buddhist Tzu Chi General Hospitallead
- Beijing Tiantan Hospitalcollaborator
Study Sites (1)
Buddhist Tzu Chi General Hospital
Hualien City, 970, Taiwan
Related Publications (6)
Kuhn J, Hardenacke K, Lenartz D, Gruendler T, Ullsperger M, Bartsch C, Mai JK, Zilles K, Bauer A, Matusch A, Schulz RJ, Noreik M, Buhrle CP, Maintz D, Woopen C, Haussermann P, Hellmich M, Klosterkotter J, Wiltfang J, Maarouf M, Freund HJ, Sturm V. Deep brain stimulation of the nucleus basalis of Meynert in Alzheimer's dementia. Mol Psychiatry. 2015 Mar;20(3):353-60. doi: 10.1038/mp.2014.32. Epub 2014 May 6.
PMID: 24798585BACKGROUNDGratwicke J, Zrinzo L, Kahan J, Peters A, Beigi M, Akram H, Hyam J, Oswal A, Day B, Mancini L, Thornton J, Yousry T, Limousin P, Hariz M, Jahanshahi M, Foltynie T. Bilateral Deep Brain Stimulation of the Nucleus Basalis of Meynert for Parkinson Disease Dementia: A Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):169-178. doi: 10.1001/jamaneurol.2017.3762.
PMID: 29255885BACKGROUNDKumbhare D, Palys V, Toms J, Wickramasinghe CS, Amarasinghe K, Manic M, Hughes E, Holloway KL. Nucleus Basalis of Meynert Stimulation for Dementia: Theoretical and Technical Considerations. Front Neurosci. 2018 Sep 3;12:614. doi: 10.3389/fnins.2018.00614. eCollection 2018.
PMID: 30233297BACKGROUNDKuhn J, Hardenacke K, Shubina E, Lenartz D, Visser-Vandewalle V, Zilles K, Sturm V, Freund HJ. Deep Brain Stimulation of the Nucleus Basalis of Meynert in Early Stage of Alzheimer's Dementia. Brain Stimul. 2015 Jul-Aug;8(4):838-9. doi: 10.1016/j.brs.2015.04.002. Epub 2015 Apr 18. No abstract available.
PMID: 25991080BACKGROUNDCanter RG, Penney J, Tsai LH. The road to restoring neural circuits for the treatment of Alzheimer's disease. Nature. 2016 Nov 10;539(7628):187-196. doi: 10.1038/nature20412.
PMID: 27830780BACKGROUNDIaccarino HF, Singer AC, Martorell AJ, Rudenko A, Gao F, Gillingham TZ, Mathys H, Seo J, Kritskiy O, Abdurrob F, Adaikkan C, Canter RG, Rueda R, Brown EN, Boyden ES, Tsai LH. Gamma frequency entrainment attenuates amyloid load and modifies microglia. Nature. 2016 Dec 7;540(7632):230-235. doi: 10.1038/nature20587.
PMID: 27929004BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shin-Yuan Chen, MD.
Buddhist Tzu Chi General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2019
First Posted
May 22, 2019
Study Start
April 6, 2020
Primary Completion
September 30, 2020
Study Completion
September 30, 2021
Last Updated
July 17, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share