Deep brain stimulation for Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research investigates the use of deep brain stimulation (DBS) targeting the pedunculopontine nucleus (PPN) as a potential treatment for Alzheimer's disease (AD). The study aims to implant an electrode in the PPN to deliver mild electrical stimulation over a 12-month period, with the goal of enhancing gamma oscillations in the brain that are often impaired in AD patients. By evaluating the safety and feasibility of this intervention, the study seeks to determine if it can improve memory and cognitive functions in individuals with mild AD. The trial will involve a small cohort of participants and is designed as an open-label, non-randomized pilot study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 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).

Where it's running

• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Taufik A. Valiante, MD PhD FRCS — University Health Network, Toronto
• Study coordinator: Delaney Sharp
• Email: delaney.sharp2@uhn.ca
• Phone: 416-918-4059

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.