RECRUITINGPhase 1INTERVENTIONAL
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
Cognitive Brain Aging Reversal From Deep Brain Stimulation for Alzheimer's Dementia: a Clinical Trial.
About This Trial
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 progression of Alzheimer's disease under the normal standard of care. The main goal of the study is to determine if DBS can sustain or improve cognition in Alzheimer's disease for at least two years. Participant data, with identifying information removed, may be shared with online repositories for comparison with trials with similar subjects.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- 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
Who Should NOT Join This Trial:
- • 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
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.
Locations (1)
Wellstar MCG Hospital, Neurology Memory Clinic
Augusta, Georgia, United States