Deep brain stimulation for Alzheimer's disease
A Pilot Clinical Trial Investigating Deep Brain Stimulation of the Pedunculopontine Nucleus for the Treatment of Alzheimer's Disease
This study is testing if a new brain stimulation technique can help improve memory and thinking skills in people with mild Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06936124 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of deep brain stimulation (DBS) targeting the pedunculopontine nucleus (PPN) as a potential treatment for Alzheimer's disease (AD). The study aims to implant an electrode in the PPN to deliver mild electrical stimulation over a 12-month period, with the goal of enhancing gamma oscillations in the brain that are often impaired in AD patients. By evaluating the safety and feasibility of this intervention, the study seeks to determine if it can improve memory and cognitive functions in individuals with mild AD. The trial will involve a small cohort of participants and is designed as an open-label, non-randomized pilot study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 60 years old diagnosed with mild Alzheimer's disease who are fluent in English and have a caregiver available.
Not a fit: Patients with significant structural brain abnormalities or other neurological or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel approach to slowing the progression of Alzheimer's disease and improving cognitive functions.
How similar studies have performed: While deep brain stimulation has shown cognitive improvements in Parkinson's dementia patients, this specific approach targeting the PPN in Alzheimer's disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults over 60 years old. * Diagnosis of Alzheimer's Disease: Satisfied the diagnostic criteria of the National Institute of Aging - Alzheimer's Association criteria for probable AD. * Clinical dementia rating scale global score of ≤ 1. * Not taking an acetylcholinesterase inhibitor and/or memantine, or taking a stable dose for at least six months. * Fluent in English. * Caregiver available to participate in the study. Exclusion Criteria: * Pre-existing structural brain abnormalities (e.g., significant white matter disease, tumor, infarction, or intracranial hematoma). * Other neurologic or psychiatric diagnoses, or medical comorbidities that would preclude patients from undergoing surgery. * Non-fluent in English (it will be very difficult to conduct standard cognitive tests in English on non-fluent English speakers. In addition, language barrier is significant hurdle in providing standard care with communication and cognition being a main outcome measure).
Where this trial is running
Toronto, Ontario
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Taufik A. Valiante, MD PhD FRCS — University Health Network, Toronto
- Study coordinator: Delaney Sharp
- Email: delaney.sharp2@uhn.ca
- Phone: 416-918-4059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.