Intermittent deep brain stimulation of the nucleus basalis to treat Alzheimer's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.