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Deep Brain Stimulation for the Treatment of Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01559220
First received: March 19, 2012
Last updated: October 21, 2016
Last verified: October 2016

March 19, 2012
October 21, 2016
March 2012
January 2016   (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.
 
Completed
3
January 2016
January 2016   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01559220
2011H0362
No
Not Provided
Not Provided
Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
Not Provided
Principal Investigator: Ali Rezai, MD Ohio State University
Ohio State University
October 2016

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