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ADvance II Study: DBS-f in Patients With Mild Alzheimer's Disease

NCT03622905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-11-05

No results posted yet for this study

Summary

The primary efficacy objective of this study is to test the hypothesis that DBS-f stimulation (ON) will slow cognitive and functional progression of AD, as compared to no stimulation (OFF), by measuring baseline (pre-implantation) to 12-month change in the integrated Alzheimer's disease rating scale (iADRS).

Conditions

  • Alzheimer Disease

Interventions

DEVICE

DBS-f On

Deep Brain Stimulation of the fornix

DEVICE

DBS Off

Deep Brain Stimulation of the fornix turned off

Sponsors & Collaborators

  • Functional Neuromodulation Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2024-02-19
Completion
2024-02-19
FDA Device
Yes

Countries

  • United States
  • Canada
  • Germany

Study Locations

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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 NCT03622905 on ClinicalTrials.gov