Brain stimulation implant tested in people with mild Alzheimer's disease
Tests a brain stimulation implant in people with mild Alzheimer's disease, for safety.
Plain-language title generated from the registry record
Registry title: Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease
Key facts
- Where
- Toronto, CanadaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults over 60 with mild Alzheimer's disease who have a caregiver. It tests a brain stimulation device implanted in the brain for 12 months.
- Age
- Over 60 years old (minimum age 60 Years).
- Sex
- All sexes can join.
- Disease stage
- Probable Alzheimer's disease by the National Institute of Aging - Alzheimer's Association criteria. Clinical dementia rating scale global score of 1 or lower.
- Earlier treatment
- People must not take an acetylcholinesterase inhibitor or memantine, or must have taken a stable dose for at least six months.
Main reasons for not taking part
- Structural brain abnormalities, such as significant white matter disease, tumor, infarction or intracranial hematoma
- Other neurologic or psychiatric diagnoses
- Medical conditions that would prevent surgery
- Not fluent in English
- No caregiver available to take part
Read by machine on 9 November 2026.
Where in Canada
- Toronto Western HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT06936124
- Record updated
- 1 May 2025
- Original description
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.Read full original descriptionShow less
A Pilot Clinical Trial Investigating Deep Brain Stimulation of the Pedunculopontine Nucleus for the Treatment of Alzheimer's Disease
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.
Inclusion: 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: 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).