Deep Brain Stimulation (DBS) for Alzheimer's Disease

NCT00658125 | Completed DMC

• 1 other identifier: 06-0095-B
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Alzheimer disease (AD) is a debilitating brain disorder that affects over 4.75 million people in the US and Canada. People with AD have difficulty remembering general facts and previously experienced autobiographical events. Animal and human research demonstrates that this type of memory depends on neural function within specific brain areas, and that it may be possible to enhance memory with electrical stimulation of these brain areas. We have recently shown that deep brain stimulation (DBS) of a brain area called the fornix enhances memory in a human. Hypotheses: We hypothesize that fornix DBS will safely enhance memory in early AD patients by activating memory circuits in the brain. Methods: Six early AD patients will take part in a phase I clinical study over a 1-year period. The study involves bilateral fornix DBS implantation, detailed neuropsychological and neurological testing, and brain imaging to detect alterations in brain activity induced by stimulation. These assessments will occur one month before surgery, then again at one month, 6 months, and 12 months after surgery.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• memory performance on neuropsychological tests

  one year

Study Arms (1)

Experimental

EXPERIMENTAL

Procedure: Bilateral fornix DBS implantation,

Interventions

Bilateral fornix DBS implantation, PROCEDURE

Fornix DBS for Alzheimer Disease

Also known as: DBS

Experimental

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 40 to 80 years old, who
• Satisfy the diagnostic criteria for probable AD,
• Have received the diagnosis of AD within the past 2 years,
• Have a CDR of 0.5 or 1.0, and
• Score between 20 and 28 on the Mini Mental State Examination

You may not qualify if:

• Pre-existing structural brain abnormalities,
• Other neurologic or psychiatric diagnoses, or
• Medical comorbidities that would preclude them from undergoing surgery

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• Hamani C, McAndrews MP, Cohn M, Oh M, Zumsteg D, Shapiro CM, Wennberg RA, Lozano AM. Memory enhancement induced by hypothalamic/fornix deep brain stimulation. Ann Neurol. 2008 Jan;63(1):119-23. doi: 10.1002/ana.21295.

  PMID: 18232017 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Adrian W Laxton, MD

  Toronto Western Research Institute

  STUDY DIRECTOR

• Andres M Lozano, MD, PhD

  Toronto Western Research Institute

  PRINCIPAL INVESTIGATOR

• David Tang-Wai, MD

  Toronto Western Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2007
• Primary Completion: June 30, 2010
• Study Completion: June 30, 2010
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

CA (1)