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NCT05882344

Cholinergic Deep Brain Stimulation for Alzheimer's Disease

Enrolling by Invitation
NAAges 60–80InterventionalTreatment
Vanderbilt University Medical Center
~2 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Device Implantation- Boston Scientific, VERCISE GENUS™ systemDBS Stimulation - Boston Scientific, VERCISE GENUS™ system

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Dementia Rating score change
Measured over 12 - 24 Months

Conditions

Alzheimer Disease, Early Onset
Dementia
Alzheimer Disease

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Dave Blake, PhD · PRINCIPAL_INVESTIGATOR · Augusta University
  • Dario Englot, MS, PhD, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Probable, early-stage AD, as defined by NIA-AA 2018 criteria, including amnestic Mild Cognitive Impairment (MCI)
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

Active or unstable psychiatric illness
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

What this trial measures

  • Clinical Dementia Rating score change12 - 24 Months

    . The primary outcome indicating success will be an increase in the mean score of the Clinical Dementia Rating - Sum of Boxes of the pre-stimulation baseline that is equal or greater than the increase in the post-stimulation data by 1 point or more, after 12-36 months of stimulation.