Cholinergic Deep Brain Stimulation for Alzheimer's Disease
NCT ID: NCT05882344
Last Updated: 2025-12-17
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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NOT_YET_RECRUITING
NA
2 participants
INTERVENTIONAL
2026-06-01
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deep Brain Stimulation
Patients who are implanted and receive intermittent stimulation daily for the first 12 months
Device Implantation- Boston Scientific, VERCISE GENUS™ system
Participants will be implanted with DBS leads bilaterally, targeting the Nucleus Basalis of Meynert. The study team will record Local Field Potentials with and without stimulation, intraoperatively. These results will help the team determine at the end of the study whether LFP desynchronization (decrease in 5-15 Hz power), or other physiological signature, can be used to predict the location that provides the most effective intervention. Finally, the team will also ascertain the safety of the procedure and NB stimulation itself.
DBS Stimulation - Boston Scientific, VERCISE GENUS™ system
Daily intermittent stimulation (60 Hz x 20s/min)
Interventions
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Device Implantation- Boston Scientific, VERCISE GENUS™ system
Participants will be implanted with DBS leads bilaterally, targeting the Nucleus Basalis of Meynert. The study team will record Local Field Potentials with and without stimulation, intraoperatively. These results will help the team determine at the end of the study whether LFP desynchronization (decrease in 5-15 Hz power), or other physiological signature, can be used to predict the location that provides the most effective intervention. Finally, the team will also ascertain the safety of the procedure and NB stimulation itself.
DBS Stimulation - Boston Scientific, VERCISE GENUS™ system
Daily intermittent stimulation (60 Hz x 20s/min)
Eligibility Criteria
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Inclusion Criteria
* Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a memory box score of at least 0.5
* MMSE ³ 23
* Stable cognitive enhancer medication equivalent to 10 mg/day donepezil or less for at least 60 days
* Stable other medications (e.g., psychotropics)
* Valid informed consent if female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study
* an available caregiver willing to participate
* subject is living at home and likely to remain at home for the study duration.
Exclusion Criteria
* Inability to tolerate general anesthesia.
* Another concurrent CNS condition or clinical co-morbidity interfering with the study (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology).
* Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
* Verbal IQ\<85
* Contraindication regarding anesthesia, stereotactic operation, MRI (e.g. claustrophobia, or implants), or PET (e.g. insulin dependent diabetes) procedures
* Inability to undergo PET or MRI imaging
* Active alcohol or substance abuse as defined by DSM5
* Is unable or unwilling to comply with protocol follow-up requirements
* Is actively enrolled in another concurrent clinical trial.
* Terminal illness associated with expected survival of \<12 months
60 Years
80 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Vanderbilt University Medical Center
OTHER
Responsible Party
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Christos Constantinidis
Professor
Principal Investigators
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Dave Blake, PhD
Role: PRINCIPAL_INVESTIGATOR
Augusta University
Dario Englot, MS, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Koh EJ, Golubovsky JL, Rammo R, Momin A, Walter B, Fernandez HH, Machado A, Nagel SJ. Estimating the Risk of Deep Brain Stimulation in the Modern Era: 2008 to 2020. Oper Neurosurg. 2021 Oct 13;21(5):277-290. doi: 10.1093/ons/opab261.
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.
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
Todd S, Barr S, Passmore AP. Cause of death in Alzheimer's disease: a cohort study. QJM. 2013 Aug;106(8):747-53. doi: 10.1093/qjmed/hct103. Epub 2013 May 7.
van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.
Williams MM, Storandt M, Roe CM, Morris JC. Progression of Alzheimer's disease as measured by Clinical Dementia Rating Sum of Boxes scores. Alzheimers Dement. 2013 Feb;9(1 Suppl):S39-44. doi: 10.1016/j.jalz.2012.01.005. Epub 2012 Aug 1.
Other Identifiers
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240675
Identifier Type: -
Identifier Source: org_study_id