Deep Brain Stimulation for the Treatment of Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559220
• Other study ID #: 2011H0362
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: March 28, 2017
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Open label pilot study

• Expected direct benefit on the modulation of neuronal networks.

• Expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities.

Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to be on study for about 23 months.

• Develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by Alzheimer's Disease.

• Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of DBS for Alzheimer's Disease patients with mild to moderate disability.

• Determine an initial DBS titration and stimulation settings protocol for use in subsequent controlled trials.

• Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments.

• Determine what domains of cognitive, behavioral and functioning impairment show the greatest response to DBS.

• Examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone.

• Evaluate the influence of DBS on physiological and functional changes in cortical and subcortical networks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Device:
• Deep Brain Stimulation
Implanted device

Locations

Country	Name	City	State
United States	Wexner Medical Center at the Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ali Rezai, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Dementia Rating Scale		24 months