Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-04-06
2021-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AD with DBS
Alzheimer's disease subjects with optimal medication therapy and with DBS treatment
Deep brain stimulation
Brain stimulation electrodes at parameters 2.0\~4.5 V；60 μs；20 Hz
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
AD without DBS
Alzheimer's disease subjects with optimal medication therapy and without DBS treatment
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
Normal control
Matched aged and demographics subjects
No interventions assigned to this group
Interventions
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Deep brain stimulation
Brain stimulation electrodes at parameters 2.0\~4.5 V；60 μs；20 Hz
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
80 Years
ALL
Yes
Sponsors
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Beijing Tiantan Hospital
OTHER
Buddhist Tzu Chi General Hospital
OTHER
Responsible Party
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Principal Investigators
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Shin-Yuan Chen, MD.
Role: PRINCIPAL_INVESTIGATOR
Buddhist Tzu Chi General Hospital
Locations
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Buddhist Tzu Chi General Hospital
Hualien City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Shin Yuan Chen, MD
Role: primary
References
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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.
Gratwicke 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.
Kumbhare 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.
Kuhn 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.
Canter 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.
Iaccarino 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.
Other Identifiers
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IRB106-68-A
Identifier Type: -
Identifier Source: org_study_id
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