The Revitalize Study in Older Adults at Risk for Alzheimer's Disease

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

August 12, 2020

Primary Completion Date

August 7, 2024

Study Completion Date

June 30, 2026

Conditions
Cognitive AgingAlzheimer Disease, Protection Against
Interventions
DEVICE

Active NIR-PBM

Near infrared light was delivered to the head using two MedX Rehab Console systems (MedX Health, 1116). Each MedX console included a control unit and 3 superluminous light emitting diode (LED) clusters. Each LED cluster (3MedX MCT502) consisted of 52 near infrared diodes and 9 visible red diodes. The 9 red diodes were deactivated. The energy delivered by each cluster was 1 joule \[J\]/cm2 in 45 sec at treatment wavelength of 870 nm per each 20 min. The LED cluster has an irradiance of 22.2 mW/cm2, treats an area of 22.48 cm2, with an energy density of 26.64/cm2 per cluster (total energy of 599J/cluster). During each session, the 6 clusters were arrayed on the scalp in 2 configurations, 20 minutes per array. Each configuration targeted 6 transcranial sites, guided by the 10-20 system, for a total of 12 sites during the 40-min session. Total energy delivered was 599J/cluster X 12 sites = 7188J. Intranasal stimulation was delivered using..

DEVICE

Sham NIR-PBM

The MedX sham and Vielight interventions device are identical in all respects to the active device, except that the MedX console and diode clusters were modified to NOT deliver NIR light when turned on. The sham MedX devices were modified to deliver 'warmth', similar to that of the active devices. As with the active condition, a total of six sham interventions were given over a 12-week period, following the identical procedures described in the active condition

Trial Locations (2)

32610

University of Florida McKnight Brain Institute, Gainesville

85721

University of Arizona, Tucson

All Listed Sponsors
collaborator

University of Arizona

OTHER

collaborator

National Institute on Aging (NIA)

NIH

lead

University of Florida

OTHER