Deep Brain Stimulation (DBS) for Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bilateral fornix DBS implantation,
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pre-existing structural brain abnormalities,
- Other neurologic or psychiatric diagnoses, or
- Medical comorbidities that would preclude them from undergoing surgery
Sites / Locations
- Toronto Western Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
memory performance on neuropsychological tests
Secondary Outcome Measures
Full Information
NCT ID
NCT00658125
First Posted
April 9, 2008
Last Updated
September 25, 2019
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00658125
Brief Title
Deep Brain Stimulation (DBS) for Alzheimer's Disease
Official Title
Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2007 (Actual)
Primary Completion Date
June 30, 2010 (Actual)
Study Completion Date
June 30, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bilateral fornix DBS implantation,
Other Intervention Name(s)
DBS
Intervention Description
Fornix DBS for Alzheimer Disease
Primary Outcome Measure Information:
Title
memory performance on neuropsychological tests
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Pre-existing structural brain abnormalities,
Other neurologic or psychiatric diagnoses, or
Medical comorbidities that would preclude them from undergoing surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian W Laxton, MD
Organizational Affiliation
Toronto Western Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andres M Lozano, MD, PhD
Organizational Affiliation
Toronto Western Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Tang-Wai, MD
Organizational Affiliation
Toronto Western Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18232017
Citation
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.
Results Reference
background
Learn more about this trial
Deep Brain Stimulation (DBS) for Alzheimer's Disease
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