A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
Part of paid clinical trials in Augusta, Georgia.
- Sponsor
- Augusta University
- Study ID
- NCT07218081
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Alzheimer Dementia (AD)
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Intermittent deep brain stimulation of the nucleus basalis of Meynert — DEVICESubjects will receive intermittent deep brain stimulation of the nucleus basalis of Meynert for 50 minutes each day.
Study Details
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.
Key Dates
- Start date
- Feb 1, 2026
- Status verified
- Jan 2026
- Primary completion
- Nov 1, 2028
- Completion
- Nov 30, 2028
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Intermittent deep brain stimulation of the nucleus basalis of MeynertSubjects 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.
- No Intervention: Control groupSubjects 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.
Primary Outcome Measure
Dementia Rating Scales [ Time Frame: Two years after intervention onset ]
Central Contacts
- David T Blake, PhD415-515-2659
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wellstar MCG Hospital, Neurology Memory Clinic | Augusta | Georgia | 30912 |
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