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NCT07218081 · ClinicalTrials.gov registry record · Phase 1
A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.
A Phase 1 study of Alzheimer Dementia (AD), sponsored by Augusta University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07218081: Recruiting Phase 1 study of Alzheimer Dementia (AD), sponsored by Augusta University.
NCT07218081 is a Phase 1 study of Alzheimer Dementia (AD) that is actively recruiting participants, run by Augusta University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07218081, a Phase 1 study of Alzheimer Dementia (AD), is actively recruiting participants, sponsored by Augusta University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Intermittent deep brain stimulation of the nucleus basalis of Meynert
Study Locations (1)
Georgia
- Wellstar MCG Hospital, Neurology Memory Clinic - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-02-01 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT07218081 shows while recruiting
NCT07218081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Alzheimer Dementia (AD) appearing as the primary indexed condition, and to 1 intervention - of which Intermittent deep brain stimulation of the nucleus basalis of Meynert is the first listed.
NCT07218081 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07218081 about?
NCT07218081 is a clinical study titled "A Trial to Test Intermittent Deep Brain Stimulation of Nucleus Basalis of Meynert to Treat Alzheimers.". 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 ...
What is the current status of trial NCT07218081?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-02-01. Estimated completion is 2028-11.
What conditions does trial NCT07218081 study?
This clinical trial studies the following conditions: Alzheimer Dementia (AD).
What interventions are being tested in trial NCT07218081?
The interventions under investigation include: Intermittent deep brain stimulation of the nucleus basalis of Meynert (DEVICE).
Who is sponsoring clinical trial NCT07218081?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07218081 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07218081's enrollment target sits among peer trials
12 1853rd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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