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Clinical Trial NCT07218081 for Alzheimer Dementia (AD) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers. Phase 1 12

Recruiting
Clinical Trial NCT07218081 is designed to study Treatment for Alzheimer Dementia (AD). It is a Phase 1 interventional study that is recruiting, having started on 1 February 2026, with plans to enroll 12 participants. Led by Augusta University, it is expected to complete by 1 November 2028. The latest data from ClinicalTrials.gov was last updated on 7 January 2026.
Brief Summary
The purpose of this study is to test a new procedure to treat Alzheimer's disease. The procedure is called intermittent Deep Brain Stimulation (DBS) of the nucleus basalis of Meynert. There will be up to six participants enrolled at Wellstar MCG Memory Clinic. There will be another six participants similarly enrolled to act as a control group that does not receive DBS. This second group will document the course of pr...Show More
Official Title

Cognitive Brain Aging Reversal From Deep Brain Stimulation for Alzheimer's Dementia: a Clinical Trial.

Conditions
Alzheimer Dementia (AD)
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2300118-2
NCT ID Number
NCT07218081
Start Date (Actual)
2026-02-01
Last Update Posted
2026-01-07
Completion Date (Estimated)
2028-11
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
deep brain stimulation
alzheimer's
nucleus basalis of Meynert
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIntermittent deep brain stimulation of the nucleus basalis of Meynert
Subjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day. Assessments will be performed at onset, after four weeks of intervention, and each six months through two years.
Intermittent deep brain stimulation of the nucleus basalis of Meynert
Subjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day.
No InterventionControl group
Subjects will have matching eligility criteria as those in the experimental arm, but will receive no intervention. Assessments will be performed at study onset, and each six months through two years after onset.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Dementia Rating Scales
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.
Two years after intervention onset
Alzheimer's Disease Assessment Scale, Cognitive Subscale
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.
Two years of intervention
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
PET scans for beta amyloid
PET scans will be obtained at onset and annually through two years. The investigators seek for a reduction in the Standard Uptake Volume Ratio (SUVr) in the intervention arm compared to the control arm. SUVr is a ratio of image intensity in a reference region of the brain compared to the cerebral cortex. SUVr averages 1.22 in subjects diagnosed with Alzheimer's, and 1.0 in non-Alzheimer's controls.
Two years after study onset.
Anxiety scales
Subjects will receive a GAD-7 questionnaire at the same times as cognitive assessments. The investigators seek for reductions in the GAD-7 values in the intervention arm compared to the control arm. The GAD-7 scale ranges from 0 to 21, and higher scores indicate more anxiety.
Two years of intervention
Beta amyloid PET imaging, Centiloid scale.
PET scans will be obtained from particpants at onset and annually through two years. The investigators seek for a reduction in the Centiloid Scale in the intervention arm compared to the control arm. The Centiloid scale is 0CL on average in a 45 year old normal, and 100CL in a person with Alzheimer's dementia.
Two years of intervention
PHQ-9 questionaire
Participants will receive a PHQ-9 questionnaire at the same times as cognitive assessments. The investigators seek for reductions in this scale in the intervention arm compared to the control arm. The PHQ-9 depression scale has scores from 0 to 27, and higher scores indicate more depression.
Two years of intervention
Participation Assistant
Eligibility Criteria

Eligible Ages
Older Adult
Minimum Age
65 Years
Eligible Sexes
All

  • 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

  • • 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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Study Responsible Party
David Blake, Principal Investigator, Professor David T. Blake, Augusta University
Study Central Contact
Contact: David T Blake, PhD, 415-515-2659, [email protected]
1 Study Locations in 1 Countries

Georgia

Wellstar MCG Hospital, Neurology Memory Clinic, Augusta, Georgia, 30912, United States
John Morgan, MD, PhD, Contact, (706) 721-4581, [email protected]
Recruiting