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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 February 2016 by Ohio State University
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University Identifier:
First received: March 19, 2012
Last updated: February 19, 2016
Last verified: February 2016

March 19, 2012
February 19, 2016
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 Archive Site
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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.
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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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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).
45 Years to 85 Years   (Adult, Senior)
Contact: Carson Reider, PhD 614-293-9274
Contact: Jennifer Icenhour, CCRP 614-293-6882
United States
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Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
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Principal Investigator: Ali Rezai, MD Ohio State University
Ohio State University
February 2016

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