Could a brain pacemaker fight Alzheimer's? new trial begins.
NCT ID NCT07218081
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure called deep brain stimulation (DBS) for people with early-stage Alzheimer's. It involves placing small electrodes in a brain area that controls memory and thinking. The goal is to see if DBS can keep thinking skills stable or improve them for at least two years. The trial will include 12 people: 6 will get DBS plus standard care, and 6 will receive only standard care for comparison.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Wellstar MCG Hospital, Neurology Memory Clinic
RECRUITINGAugusta, Georgia, 30912, United States
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