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

StatusCompleted
PhasePhase 2
Started2020-08-12
View on ClinicalTrials.gov ↗

Amendment history

2026-09-22
Trial completed
2025-09-23
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v13
Results first postednot stated→2025-10-09
Secondary endpointsdetails revised at 1 of 1 entry
2025-08-19
Study Status, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, Limitations and Caveats, More Information v12
Secondary endpoints1 entry, revised
Change in Active groupGroup functionalNetwork connectivitySegregation comparedCompared to Sham groupGroup
Primary endpoints1 entry, revised
Change in Active groupGroup ARENA scoresComposite comparedScore Compared to Sham groupGroup ARENA scoresComposite Score
2025-08-01
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Document Section v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-04→confirmed 2024-08-07
Completion date2025-04→2026-06-30
Eligibility criteria+120 characters
[...] e within normal limits for age, education and sex using the National Alzheimer's Coordinating Center (NACC) Uniform Data Set (UDS) norms. No psychometric evidence of c [...] t, version 3. Scores on these measures cannot be lower than 1.05th SD (16th %ile)percentile below normative values based on age, education, and gender. [...] tion measures on a computer In line with recommendations of the Subjective Cognitive Decline (SCD) task force an informant must be available for two reasons: [...] ltiple sclerosis, seizure disorder, brain surgery, moderate TBItraumatic brain injury (TB)I, Rapid Eye Movement (REM) Behavi [...]
Secondary endpoints+69 characters
Change in Active group functional connectivity compared to Sham group
Study description+113 characters
This multi-site randomized sham-controlled trial proposes to test a novel, non-invasive, low risk and low-cost brain stimulation approach for enhancing cognition and [...] s in Magnetic Resonance Spectroscopy (MRS)-based markers of adenosine triphosphate (ATP), neural network changes as indexed by changes in functional connectivity based on resting state-fMRI (rs-fMRI), and improved cognitive performance. We plan to randomize 1 [...] standardized neuropsychological measures must be unimpaired psychometricallylpsychometrically. The intervention itself will last for 12 weeks and include [...] gation that is linked [...]
Study sitesdetails revised at 2 of 2 sites
2024-05-07
Study Status v10
Primary completion date2024-04→2025-04
Completion date2024-04→2025-04
Show 9 earlier versions
2023-07-24
2 amendments v8-v9
2 re-verifications since 2022-06-28, no change to tracked fields
2021-04-26
Study Identification, Study Status, Study Description, Study Design v7
Study description+3,151 characters
This multi-site randomized sham controlled trial proposes to test a novel, non-invasive, low risk and low cost brain stimulation approach for enhancing cognition and brain health in cognitively normal older adults who are at increased risk for Alzheimer's disease. The intervention involves transcran [...]
Study title+48 characters
The Revitalize Study in Older Adults at Risk for Alzheimer's Disease
2021-04-14
Study Status v6
Primary completion date2025-01→2024-04
Completion date2025-01→2024-04
2021-02-17
Study Identification, Study Status v5
Re-verified, no change to tracked fields
2020-09-24
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-08→confirmed 2020-08-12
Study sitesdetails revised at 2 of 2 sites
2020-07-06
Study Status v3
Start date2020-06→2020-08
2020-02-13
Study Status v2
Start date2020-01→2020-06
2019-07-12
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2019-07-10
Original filing
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 provide the necessary data for a future Phase III randomized clinical trial.
Trial Details
NCT Number NCT04018092
Lead Sponsor University of Florida
Collaborators: University of Arizona, National Institute on Aging (NIA)
Conditions Cognitive Aging, Alzheimer Disease, Protection Against
Enrollment 168 participants
Start Date 2020-08-12
Primary Completion 2024-08-07 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-21