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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
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• 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.

Locations
Other Locations
Canada
Toronto Western Hospital
RECRUITING
Toronto
Contact Information
Primary
Delaney Sharp
delaney.sharp2@uhn.ca
416-918-4059
Backup
Steven Carcone
steven.carcone@uhn.ca
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2028-11
Participants
Target number of participants: 6
Treatments
Experimental: Deep Brain Stimulation of the Pedunculopontine Nucleus
The experimental intervention employs deep brain stimulation (DBS), a neuromodulation therapy involving the precise application of electrical impulses to targeted brain regions (the PPN) to modulate neural activity. The study intervention will span 12 months, with key milestones including DBS-PPN implantation, DBS activation and initial programming, and follow-up assessments at 3-month intervals. These follow-up visits will assess safety, feasibility, electrographic measures, and cognitive outcomes.~All patient participants will receive the experimental intervention. This is the only arm in this study.
Sponsors
Leads: University Health Network, Toronto
Collaborators: Alzheimer Society of Canada, Brain Canada

This content was sourced from clinicaltrials.gov