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

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Conditions

Cognitive AgingAlzheimer Disease, Protection Against

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Revitalizing Cognition in Older Adults at Risk for Alzheimer's Disease With Near-Infrared Photobiomodulation

Quick Facts

Study Start:2020-08-12
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04018092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 65-89 years, at least 8th grade education, community dwelling
  2. * Subjective report of cognitive complaints with scores \>16 on the Cognitive Change Index (CCI-20)
  3. * No evidence of dementia or mild cognitive impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education and sex using the National Alzheimer's Coordinating Center (NACC) Uniform Data Set (UDS) norms.
  4. * No psychometric evidence of cognitive impairment based on performance on the Neuropsychological Battery from the NACC Unified Data Set, version 3. Scores on these measures cannot be lower than 5th percentile below normative values based on age, education, and gender.
  5. * Reading at \> 8th grade level based on the reading subtest of the Wide Range Achievement Test- IV.
  6. * Global Clinic Dementia Rating (CDR) score must be 0
  7. * Family history of dementia/probable Alzheimer's disease in first degree relative (parents, children, siblings)
  8. * Willingness to be randomized to Sham or Active Intervention
  9. * Can devote 12 weeks to the intervention with additional time for pre and post testing
  10. * Normal functional behavior in terms of daily activities, based on the Functional Activities Scale
  11. * Able to perform cognitive and emotion measures on a computer
  12. * In line with recommendations of the Subjective Cognitive Decline (SCD) task force an informant must be available for two reasons: a) to provide information about the participant's complaints using the informant version of the CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire.
  1. * Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
  2. * English as a second language
  3. * Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
  4. * Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g.,Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate traumatic brain injury (TB)I, Rapid Eye Movement (REM) Behavior Sleep Disorder, untreated sleep apnea, etc.)
  5. * Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis.
  6. * Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months.
  7. * Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
  8. * Use of prescribed 'memory enhancing' medications such as Aricept or Namenda
  9. * Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention.
  10. * Previous participation in a cognitive training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of participation

Contacts and Locations

Principal Investigator

Dawn Bowers, Ph.D
PRINCIPAL_INVESTIGATOR
University of Florida
Steve DeKosky, M.D.
PRINCIPAL_INVESTIGATOR
University of Florida
Gene Alexander, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Arizona

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85721
United States
University of Florida McKnight Brain Institute
Gainesville, Florida, 32610
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Dawn Bowers, Ph.D, PRINCIPAL_INVESTIGATOR, University of Florida
  • Steve DeKosky, M.D., PRINCIPAL_INVESTIGATOR, University of Florida
  • Gene Alexander, Ph.D., PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-12
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2020-08-12
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cognitive Aging
  • Alzheimer Disease, Protection Against