NCT01559220

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

March 19, 2012

Last Update Submit

March 28, 2017

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical Dementia Rating Scale

    24 months

Study Arms (1)

Open Label

EXPERIMENTAL

DBS Implant and stimulation

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE

Implanted device

Also known as: Deep Brain Stimulation Device
Open Label

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wexner Medical Center at the Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Ali Rezai, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

March 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)