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NCT04018092 · ClinicalTrials.gov registry record · Phase 2
The Revitalize Study in Older Adults at Risk for Alzheimer's Disease
A Phase 2 study of Cognitive Aging and Alzheimer Disease, Protection Against, sponsored by University of Florida.
- Active
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 2
- Study locations
NCT04018092 is a Phase 2 study of Cognitive Aging and Alzheimer Disease, Protection Against that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 168 participants, below the 501-participant average among 5 other Cognitive Aging trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04018092, a Phase 2 study of Cognitive Aging and Alzheimer Disease, Protection Against, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this multi-site double blinded randomized sham-controlled Phase II clinical trial is to test a novel, relatively low cost, low risk, and potentially high impact therapeutic intervention in older adults who are at increased risk for Alzheimer's disease. The intervention involves transcranial and intranasal delivery of near infrared (NIR) light via light emitting diodes, aka photobiomodulation (PBM). The overall hypothesis, based on animal and pilot studies, is that exposure to NIR stimulation will have beneficial effects on brain health via influence on mitochondrial function as measured by changes in 31Phosphorous (31P) MRS-based markers of ATP, neural network changes in functional connectivity (rs-fMRI), and improved cognitive performance. To test this hypothesis, 168 older adults with subjective cognitive complaints, and a first-degree family history of Alzheimer's disease will be randomized to sham or real treatment groups. Neuroimaging and cognitive outcome measures will be obtained, before and after a 12-week intervention involving transcranial and intranasal NIR-PBM. The intervention protocol will involve "lab" and "home" sessions, and a 3 month post-intervention follow-up. This trial will determine: 1) whether NIR stimulation, relative to sham, improves performance on memory and executive tasks sensitive to hippocampal and frontal brain function in older adults with increased risk for Alzheimer's disease; 2) whether NIR stimulation, relative to sham, enhances brain function and connectivity measured by changes in MRS phosphorous ATP and resting state functional connectivity; and 3) how differences in demographic, neuroimaging, and Alzheimer-related risk factors influence the brain response to NIR stimulation versus sham in older adults with increased risk for Alzheimer's disease. Results will provide key insights into whether this novel NIR intervention can enhance cognition in older adults with increased risk for Alzheimer's disease and will prov
Conditions Studied
Interventions
- DEVICE Active NIR-PBM
- DEVICE Sham NIR-PBM
Study Locations (2)
Arizona
- University of Arizona - Tucson
Florida
- University of Florida McKnight Brain Institute - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04018092
The ClinicalTrials.gov registry entry for NCT04018092 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 501-participant average among 5 other Cognitive Aging trials with a reported enrollment target (66% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cognitive Aging appearing as the primary indexed condition, and to 2 interventions - of which Active NIR-PBM is the first listed.
NCT04018092 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT04018092 about?
NCT04018092 is a clinical study titled "The Revitalize Study in Older Adults at Risk for Alzheimer's Disease". The goal of this multi-site double blinded randomized sham-controlled Phase II clinical trial is to test a novel, relatively low cost, low risk, and potentially high impact therapeutic intervention in older adults who are at increased risk for Alzheimer's disease. The intervention involves transcran...
What is the current status of trial NCT04018092?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2020-08-12. Estimated completion is 2026-06-30.
What conditions does trial NCT04018092 study?
This clinical trial studies the following conditions: Cognitive Aging, Alzheimer Disease, Protection Against.
What interventions are being tested in trial NCT04018092?
The interventions under investigation include: Active NIR-PBM (DEVICE), Sham NIR-PBM (DEVICE).
Who is sponsoring clinical trial NCT04018092?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04018092 being conducted?
This trial has 2 study locations across Arizona, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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