Overview

This trial is active, not recruiting.

Condition alzheimer disease
Treatment deep brain stimulation (fornix dbs)
Phase phase 1
Sponsor University Health Network, Toronto
Start date March 2007
End date June 2010
Trial size 6 participants
Trial identifier NCT00658125, 06-0095-B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
memory performance on neuropsychological tests
time frame: one year

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

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

Additional Information

Official title Modulation of Cognitive Function Using Electrical Brain Stimulation in Patients With Early Alzheimer Disease
Principal investigator Andres M Lozano, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.