A Phase 1 interventional study of Intermittent deep brain stimulation of the nucleus basalis of Meynert in Alzheimer Dementia (AD), sponsored by Augusta University. Recruiting at 1 site in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Augusta University · Phase 1, Interventional, and Treatment
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 12 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age:65 minimum
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 space-occupying lesion on brain CT or MRI), or other implant precluding high field MRI scans.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Intermittent deep brain stimulation of the nucleus basalis of Meynert
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.
Subjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day.
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.
Time frame: 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.
Time frame: Two years of intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Two years of intervention
Plan to share: Yes — Subject data will be de-identified. Assessment outcomes and imaging results will be uploaded to open access websites for sharing such data like ADNI.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be shared upon publication and will be available indefinitely.
Access criteria: Access will be open.
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