Deep Brain Stimulation for Alzheimer's Disease
(DBS-PPN-AD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must not be taking an acetylcholinesterase inhibitor or memantine unless you have been on a stable dose for at least six months.
What data supports the effectiveness of the treatment Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease?
Deep Brain Stimulation of the Pedunculopontine Nucleus has shown promise in improving gait and reducing falls in patients with Parkinson's disease, suggesting it may help with movement-related symptoms. However, its effectiveness specifically for Alzheimer's Disease is not directly supported by the available research.12345
Is deep brain stimulation of the pedunculopontine nucleus safe for humans?
How is Deep Brain Stimulation of the Pedunculopontine Nucleus different from other treatments for Alzheimer's Disease?
Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus is unique because it targets a specific area of the brain to potentially improve symptoms like gait and balance, which is different from typical Alzheimer's treatments that focus on medication to manage memory and cognitive symptoms. This approach is novel as it uses electrical stimulation rather than drugs.236910
What is the purpose of this trial?
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.
Research Team
Taufik A. Valiante, MD PhD FRCS
Principal Investigator
University Health Network, Toronto
Eligibility Criteria
This trial is for individuals with mild Alzheimer's Disease. Participants will have a device implanted in their brain to stimulate the pedunculopontine nucleus and must attend regular follow-up appointments over 12 months. Caregivers are also involved in providing information.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
DBS Implantation
Participants undergo a procedure to implant the DBS device in the PPN, followed by an overnight hospital stay for safety monitoring
Treatment
Participants receive deep brain stimulation of the PPN over a 12-month period, with regular follow-up visits every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cognitive assessments and caregiver questionnaires
Treatment Details
Interventions
- Deep Brain Stimulation of the Pedunculopontine Nucleus
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Alzheimer Society of Canada
Collaborator
Brain Canada
Collaborator