Cholinergic Deep Brain Stimulation for Alzheimer's Disease

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called Deep Brain Stimulation (DBS) to help people with early-stage Alzheimer's disease. Researchers believe that stimulating a specific area of the brain, known as the Nucleus Basalis of Meynert, could improve thinking and memory skills and possibly slow down the progression of the disease. Participants in the study will receive tiny electrodes implanted in their brains that deliver short bursts of electrical stimulation for one hour each day. The goal is to see if this treatment can enhance cognitive function and improve brain health by targeting important brain chemicals.

To be eligible for this study, participants need to be recently diagnosed with early-stage Alzheimer's disease and show specific signs of memory issues. They should also be stable on certain medications for at least two months and have a caregiver who can help during the study. Throughout the trial, participants will undergo tests to monitor their cognitive abilities and brain function. It's important to note that participants must not have severe psychiatric conditions or other major health issues that could interfere with the study. This trial is not yet recruiting, but it aims to find new ways to help those affected by Alzheimer's disease improve their daily lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Probable, early-stage AD, as defined by NIA-AA 2018 criteria, including amnestic Mild Cognitive Impairment (MCI)
• • Clinical Dementia Rating (CDR) global score of 0.5-1.0 with a memory box score of at least 0.5
• • MMSE ³ 23
• • Stable cognitive enhancer medication equivalent to 10 mg/day donepezil or less for at least 60 days
• • Stable other medications (e.g., psychotropics)
• • Valid informed consent if female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study
• • an available caregiver willing to participate
• • subject is living at home and likely to remain at home for the study duration.
• Exclusion Criteria:
• • Active or unstable psychiatric illness
• • Inability to tolerate general anesthesia.
• • Another concurrent CNS condition or clinical co-morbidity interfering with the study (ie, stroke, Parkinson's disease, Lewy-Body dementia or other form of dementia, other evidence of significant structural brain pathology).
• • Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
• • Verbal IQ\<85
• • Contraindication regarding anesthesia, stereotactic operation, MRI (e.g. claustrophobia, or implants), or PET (e.g. insulin dependent diabetes) procedures
• • Inability to undergo PET or MRI imaging
• • Active alcohol or substance abuse as defined by DSM5
• • Is unable or unwilling to comply with protocol follow-up requirements
• • Is actively enrolled in another concurrent clinical trial.
• • Terminal illness associated with expected survival of \<12 months