- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00658125
Deep Brain Stimulation (DBS) for Alzheimer's Disease
Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
|
Fornix DBS for Alzheimer Disease
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
memory performance on neuropsychological tests
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Study Director: Adrian W Laxton, MD, Toronto Western Research Institute
- Principal Investigator: Andres M Lozano, MD, PhD, Toronto Western Research Institute
- Principal Investigator: David Tang-Wai, MD, Toronto Western Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-0095-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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