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Trial of Intermittent Deep Brain Stimulation for Alzheimer's Disease

This study is testing a new procedure called intermittent Deep Brain Stimulation (DBS) of the nucleus basalis of Meynert to treat early-stage Alzheimer's disease. DBS involves sending small electrical pulses to a specific area of the brain. The study aims to see if this treatment can help maintain or improve your thinking and memory skills for at least two years. You may be eligible if you are between 65 and 85 years old, have probable early-stage Alzheimer's disease with positive amyloid PET scans, and meet specific cognitive criteria. The study is currently recruiting participants.

Study design
This study will enroll 12 participants. Six participants will receive the DBS treatment, and another six will be a control group receiving standard care without DBS.
What's involved
If you are in the treatment group, you will receive intermittent deep brain stimulation for 50 minutes each day. The study will measure your cognitive abilities using dementia rating scales and the Alzheimer's Disease Assessment Scale, Cognitive Subscale.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive abilities will be measured for two years after the intervention begins.

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NCT07218081

A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.

Recruiting
PHASE1Ages 65–85InterventionalTreatment
Augusta University
~12 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Intermittent deep brain stimulation of the nucleus basalis of Meynert

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dementia Rating Scales
Measured over Two years after intervention onset
+1 more outcome measured

Conditions

Alzheimer Dementia (AD)

Explore related trials

Alzheimer's DiseaseAmyloid beta peptide

Where it's being run

1 sites across 1 states
Georgia1

Who to contact

David T Blake, PhD
[email protected]
415-515-2659
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

• 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

What this trial measures

  • Dementia Rating ScalesTwo years after intervention onset

    Subjects will be evaluated using the Clinical Dementia Rating Sum of Boxes scale. The investigators seeks for half of the intervention arm participants to have better (lower) or equal scale scores two years after intervention onset than they had at onset. This scale ranges from 0 to 18, and subjects will score from 2 to 6 at study entry.

  • Alzheimer's Disease Assessment Scale, Cognitive SubscaleTwo years of intervention

    The investigators seeks for scores on the Alzheimer's Disease Assessment Scale, Cognitive Subscale, to be equal or lower in half of the participants two years after the intervention begins compared to their value at study onset. This scale ranges from 0 to 85, and subjects at onset will likely have scores between 13 and 30.