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Deep Brain Stimulation in Alzheimer's Disease: Biomarkers and Dose Optimization

NCT04856072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-12-05

No results posted yet for this study

Summary

Title:

Deep Brain Stimulation of the Fornix in Alzheimer's Disease: Investigating clinical and imaging biomarkers and dose optimization

Objective:

To evaluate the influence of deep brain stimulation in Alzheimer's Disease (AD)on markers of AD pathology in cerebrospinal fluid (CSF) and on neuroimaging with positron emission tomography (PET) and to optimize electrical stimulation parameters.

Population size:

Twelve (12) patients will be recruited and enrolled in this study.

Study design:

This is a prospective, open-label trial designed to study the effect of brain stimulation on CSF and brain amyloid pathology in AD. In addition, patients will undergo neuropsychological testing at various stimulation settings to help determine optimal stimulation parameters.

Study duration:

Patients will complete screening and baseline assessments before undergoing DBS implantation surgery, after which they will be followed-up for 12 months.

Conditions

  • Alzheimer Disease

Interventions

DEVICE

Deep Brain Stimulation

Personalized Deep Brain Stimulation of Fornix

Sponsors & Collaborators

Principal Investigators

  • Andres Lozano, MD, PhD · University Health Network, Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-19
Primary Completion
2023-12-05
Completion
2023-12-05
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856072 on ClinicalTrials.gov