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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD with DBS | Experimental | Alzheimer's disease subjects with optimal medication therapy and with DBS treatment |
|
| AD without DBS | Active Comparator | Alzheimer's disease subjects with optimal medication therapy and without DBS treatment |
|
| Normal control | No Intervention | Matched aged and demographics subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | Brain stimulation electrodes at parameters 2.0~4.5 V；60 μs；20 Hz |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
For groups (AD with/ without DBS)
For normal control group
Exclusion Criteria:
For groups (AD with/ without DBS)
For normal control group
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shin-Yuan Chen, MD. | Contact | +886-3-8561825 | 12151 | william.sychen@msa.hinet.net |
| Ting-Wen Hou, BS. | Contact | +886-3-8561825 | 12151 | tcpdcenter@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shin-Yuan Chen, MD. | Buddhist Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi General Hospital | Recruiting | Hualien City | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24798585 | Background | 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. | |
| 29255885 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| D016564 | Amyloid beta-Protein Precursor |
| D000068836 | Rivastigmine |
| D008559 | Memantine |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058227 | Amyloidogenic Proteins |
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| Best medical treatment for Alzheimer's disease | Drug | Alzheimer's disease patients take medications including Exelon (Rivastigmine Tartrate), Witgen (Memantine) for at least 3 months without plan of dosage adjustment |
|
|
| Background |
| 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. |
| 30233297 | Background | 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. |
| 25991080 | Background | 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. |
| 27830780 | Background | 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. |
| 27929004 | Background | 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000682 | Amyloid |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011498 | Protein Precursors |
| D058255 | Protease Nexins |
| D053491 | Proteinase Inhibitory Proteins, Secretory |
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |