Who is eligible for clinical trial NCT06936124?

Participants must meet the protocol's inclusion criteria for Alzheimer Disease. The stated age range is 60 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06936124 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-04-28

Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease (NCT06936124)

A Pilot Clinical Trial Investigating Deep Brain Stimulation of the Pedunculopontine Nucleus for the Treatment of Alzheimer's Disease

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: University Health Network, Toronto

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (4 items).

Location: Toronto Western Hospital — Toronto, Ontario

Age range: 60 Years

🧪 Interventions in This Study

Deep Brain Stimulation of the Pedunculopontine Nucleus (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Toronto Western Hospital — Toronto, Ontario

📞 Contact the Study Coordinator

Phone: (416) 918-4059

Email: delaney.sharp2@uhn.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗