Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
Healthy Volunteers
NCT06936124

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

Led by University Health Network, Toronto · Updated on 2025-05-01

6

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

A

Alzheimer Society of Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 60 years old
  • Diagnosis of probable Alzheimer's Disease according to National Institute of Aging - Alzheimer's Association criteria
  • Clinical dementia rating scale global score of 64 1
  • Either not taking acetylcholinesterase inhibitors or memantine, or on a stable dose for at least six months
  • Fluent in English
  • Caregiver available to participate in the study
Not Eligible

You will not qualify if you...

  • Pre-existing structural brain abnormalities such as significant white matter disease, tumor, infarction, or intracranial hematoma
  • Other neurological or psychiatric diagnoses or medical conditions that prevent surgery
  • Not fluent in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

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Research Team

D

Delaney Sharp

CONTACT

S

Steven Carcone

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Deep Brain Stimulation of the Pedunculopontine Nucleus for Alzheimer's Disease | DecenTrialz