NCT06936124 Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease
| NCT ID | NCT06936124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-05 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2025-05 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Alzheimer's disease (AD) is a brain disorder that gradually impacts cognitive functions such as memory, thinking, and daily functioning. Gamma oscillations are a type of brain activity thought to play a role in memory and cognition (thinking abilities). In AD, these oscillations are impaired - meaning they are smaller and slower than the brain waves observed in healthy individuals. Research suggests that enhancing these brain waves may help slow the progression of AD. This research is investigating a technique called deep brain stimulation (DBS) of the pedunculopontine nucleus (PPN) as an experimental intervention. An electrode will be implanted in the PPN and deliver mild stimulation over the course of a 12-month period. As a novel intervention, the priority of the study is to determine if DBS-PPN is a safe and feasible intervention for mild-AD. Additionally, the study investigators are evaluating whether DBS-PPN can increase natural gamma oscillations in ways that improve memory and cognition. The insights from this study will guide the design of an accessible larger trial to more definitively assess how effective DBS-PPN could be as a treatment for AD. Participants will: * Undergo a 12-month experimental intervention involving DBS of the PPN. The procedure for implanting the DBS device takes approximately 2-3 hours under general anesthesia, followed by an overnight stay in the hospital for safety monitoring. * Be required to attend regular appointments every 3 months from DBS implantation for the duration of the study. The follow-up visits will include safety and feasibility monitoring, brain scans (EEG and MEG), and cognitive assessments/questionnaires. * Participants' caregiver will also complete questionnaires about their cognition, functioning, and overall health at the follow-up visits.
Eligibility 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).
Contact & Investigator
Taufik A. Valiante, MD PhD FRCS
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT06936124 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06936124 currently recruiting?
Yes, NCT06936124 is actively recruiting participants. Contact the research team at delaney.sharp2@uhn.ca for enrollment information.
Where is the NCT06936124 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06936124 clinical trial?
NCT06936124 is sponsored by University Health Network, Toronto. The principal investigator is Taufik A. Valiante, MD PhD FRCS at University Health Network, Toronto. The trial plans to enroll 6 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.