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Deep Brain Stimulation for the Treatment of Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01559220
First received: March 19, 2012
Last updated: June 25, 2014
Last verified: June 2014

March 19, 2012
June 25, 2014
March 2012
January 2017   (final data collection date for primary outcome measure)
Clinical Dementia Rating Scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01559220 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for the Treatment of Alzheimer's Disease
Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease

The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Device: Deep Brain Stimulation
Implanted device
Other Name: Deep Brain Stimulation Device
Experimental: Open Label
DBS Implant and stimulation
Intervention: Device: Deep Brain Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2018
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

Exclusion Criteria:

  • Has significant neurological disease, other than Alzheimer's disease, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
  • Evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (DSM-IV Criteria).
Both
45 Years to 85 Years
No
Contact: Phuong Nguyen, MBA, CCRP 6143666952 phuong.nguyen2@osumc.edu
Contact: Jennifer Icenhour, CCRP 614-293-6882 Jennifer.Icenhour@osumc.edu
United States
 
NCT01559220
DBS for AD
No
Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
Not Provided
Principal Investigator: Ali Rezai, MD Ohio State University
Ohio State University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP