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 — DEVICE
    Subjects 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 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.
  • No Intervention: Control 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.

Primary Outcome Measure

Dementia Rating Scales [ Time Frame: Two years after intervention onset ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellstar MCG Hospital, Neurology Memory ClinicAugustaGeorgia30912
John Morgan, MD, PhD
(706) 721-4581

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