Intermittent deep brain stimulation of the nucleus basalis to treat Alzheimer's
Cognitive Brain Aging Reversal From Deep Brain Stimulation for Alzheimer's Dementia: a Clinical Trial.
PHASE1 · Augusta University · NCT07218081
This will test whether intermittent deep brain stimulation of a small brain region called the nucleus basalis can help sustain or improve thinking and memory in people aged 65–85 with early-stage Alzheimer's disease.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Augusta University (other) |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT07218081 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-site interventional study implants intermittent deep brain stimulation leads in the nucleus basalis of Meynert and follows participants for at least two years. Up to six participants will receive DBS and up to six similar participants will be followed as a control group receiving standard care without DBS. Eligible participants are 65–85 years old with probable early-stage Alzheimer's confirmed by positive amyloid PET and meet cognitive and psychiatric stability criteria. De-identified participant data may be shared with online repositories for comparison with similar trials.
Who should consider this trial
Good fit: Ideal candidates are people aged 65–85 with probable early-stage Alzheimer's (NIA‑AA criteria) with positive amyloid PET, CDR 0.5–1.0, MMSE ≥21, stable on low-dose cholinergic medications, living at home with an available caregiver, and without other major neurological or psychiatric comorbidities.
Not a fit: People with more advanced dementia, other types of dementia (for example Lewy body dementia), major psychiatric or medical comorbidities, or who cannot attend the single-site follow-up visits are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the procedure could help sustain or improve cognition and slow clinical decline in people with early Alzheimer's disease.
How similar studies have performed: Previous small, early-phase DBS studies for Alzheimer's (including fornix and nucleus basalis targets) have shown mixed, preliminary results, so this approach remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age:65 minimum * Age:85 maximum * Probable, early-stage Alzheimer's Disease, as defined by NIA-AA 2018 criteria and positive PET for beta amyloid, * no Lewy-Body-dementia or other form of dementia * Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a CBR-sb score from 2 to 6. * MMSE ≥ 21 * stable psychopharmacological medication equivalent to 10 mg/day donepezil or less for at least 60 days * valid informed consent * an available caregiver willing to participate * subject is living at home and likely to remain at home for the study duration * Geriatric Depression Scale of 5 or less * Columbia Suicide Severity Rating Scale "No" on questions 3 through 5 * Neuropsychiatric Inventory (NPI-Q) under 2 on 'Delusions', 'Hallucinations' or 'Agitation/Aggression' subscales Exclusion Criteria: * • clinical co-morbidity interfering with study (e.g. head trauma requiring medical treatment in the 2 years prior, brain tumor, subdural hematoma, or other clinically significant space-occupying lesion on brain CT or MRI), or other implant precluding high field MRI scans. * current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit, or past medical history prior suicidal attempts or suicidal crises * Another concurrent CNS condition (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology). * Medical history of seizure disorder including epilepsy * Terminal illness associated with expected survival of \<30 months * Subjects with one of these other forms of dementia in the DSM-5 heading of Neurocognitive Disorders: Lewy body disease, Frontotemporal lobar degeneration, Vascular disease, Traumatic brain injury, HIV infection, Prion disease, Parkinson's disease, Huntington's disease, or due to multiple etiologies * Subjects with unstable medical and neurological conditions at the discretion of the Principle Investigator
Where this trial is running
Augusta, Georgia
- Wellstar MCG Hospital, Neurology Memory Clinic — Augusta, Georgia, United States (RECRUITING)
Study contacts
- Study coordinator: David T Blake, PhD
- Email: dblake@augusta.edu
- Phone: 415-515-2659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Dementia, deep brain stimulation, alzheimer's, nucleus basalis of Meynert