NCT05882344Enrolling by invitation
Cholinergic Deep Brain Stimulation for Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
This project will investigate the potential of Deep Brain Stimulation to improve cognitive abilities and counteract the effects of Alzheimer's disease. Deep Brain Stimulation electrodes targeting the Nucleus Basalis of Meynert (NB) will be implanted bilaterally in a cohort of patients. NB is the sole source of acetylcholine to the neocortex. Such stimulation may not only treat the cognitive symptoms but may have disease-modifying effects. Drawing from animal experiments in non-human primates that showed success of this approach, intermittent stimulation will be delivered at 60 pulses per second for 20 seconds of each minute for one hour per day. The study team will recruit patients, shortly after first being diagnosed with Alzheimer's disease. The study design will test the safety and efficacy of stimulation, potential benefits in cognitive function assessed with a battery of neurocognitive tests, cholinergic neurotransmission evaluated with Positron Emission Tomography, and ability to reverse Alzheimer's biomarkers, including beta amyloid and tau in the cerebrospinal fluid. Successful completion of this project will lead to a potential new intervention for the cognitive impairments of Alzheimer's disease.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 2 (estimated)
- First submitted
- 19 May 2023
- Start date
- Nov 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Alzheimer disease
- NCT number
- NCT05882344
What you commit to
- Study type: Interventional
- Planned participants: 2
- From Nov 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Is actively enrolled in another concurrent clinical trial.
Other illness
- Active or unstable psychiatric illness
- Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
- Contraindication regarding anesthesia, stereotactic operation, MRI (e.g. claustrophobia, or implants), or PET (e.g. insulin dependent diabetes) procedures
- Terminal illness associated with expected survival of \<12 months
Other
- Inability to tolerate general anesthesia.
- Verbal IQ\<85
- 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
Who the study is looking for
- 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.
Age in the registry: 60 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.