Deep Brain Stimulation for the Treatment of Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Device: Deep Brain Stimulation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br>DBS Implant and stimulation | Device: Deep Brain Stimulation<br>* Implanted device<br>* Other names: Deep Brain Stimulation Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Dementia Rating Scale |  | 24 months |