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ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease

NCT01608061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-08-31

Study results available
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Summary

The primary objective of this feasibility study is to evaluate the safety of DBS-f in patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse events. The secondary objective is to preliminarily estimate the treatment effect size on the outcomes of interest at 12 months post-randomization. The objectives do not involve formal tests of hypotheses.

Conditions

  • Alzheimer Disease

Interventions

DEVICE

DBS-f on

deep brain stimulation of the fornix

DEVICE

DBS-f off

deep brain stimulation of the fornix turned off

Sponsors & Collaborators

  • Functional Neuromodulation Ltd

    lead INDUSTRY

Principal Investigators

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

  • Constantine G Lyketsos, MD, MHS, DFAPA, FAPM · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-06-30
Completion
2018-09-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT01608061 on ClinicalTrials.gov