Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Revitalize Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04018092
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
University of Arizona
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date February 17, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
Change in Active group ARENA scores compared to Sham group ARENA scores [ Time Frame: Baseline; Week 12 ]
The primary outcome measure is a spatial navigation task (ARENA), a human analogue to the Morris WaterMaze. Participants navigate a virtual room on a computer. The task consists of 3 phases: practice, learning, and memory probe. During the learning trials, the target is invisible until the participant hovers over it. The target is located in the same location and the participant must use spatial cues to locate it. In the memory probe trial, the target is removed unbeknownst to the participant. On each learning trial, path length, time to acquire the target, and target acquisition (yes-no) are recorded. On the probe trial, path length and percent of time spent in each quadrant are recorded. The primary outcome is a composite z score, consisting of mean z scores for the following: path length(.25 weight)+time to acquire target (.25 weight)+time spent in proximal target on trial 9(.50 weight). Higher Z scores indicate better performance. Expected range of composite Z is -4 to 4.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2019)
Change in Active group ARENA scores compared to Sham group ARENA scores [ Time Frame: Baseline; Week 12 ]
The primary outcome measure will be a spatial navigation task (ARENA), a human analogue to the Morris WaterMaze. Participants navigate in a virtual 3-D room displayed on a computer screen. The goal is to find the target on the floor as quickly as possible. The task consists of 3 phases: practice, learning, and memory probe. Practice trials have a visible target on the floor that is easy to locate. During the learning trials, the target is invisible until the participant hovers over it. The target is always located in the same spatial location and the participant must use spatial cues to locate the target. In the final memory probe trial, the target is removed unbeknownst to the participant. On each learning trial, path length, time to acquire the target, and target acquisition (yes-no) are recorded. On the probe trial, path length and percent of time spent in each quadrant of the Arena are recorded. The primary outcome variable for is a composite score, consisting of mean z-sc.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Revitalize Study
Official Title  ICMJE Revitalizing Cognition in Older Adults at Risk for Alzheimer's Disease With Near-Infrared Photobiomodulation
Brief Summary There is a great need for effective treatments and prevention therapies that can provide symptomatic and disease modifying benefits for those at risk for Alzheimer's disease. The proposed multi-site collaborative project brings together research teams at the University of Florida (UF) and University of Arizona (UA) 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. Prior research in cellular and animal models suggest that red and infrared light are neuroprotective and thought to improve mitochondrial function by promoting increased production of intracellular ATP. Transgenic mouse models of Alzheimer's disease demonstrate reduced beta-amyloid and neurofibrillary tangles in response to transcranial NIR versus sham stimulation. Preliminary human studies have also shown promising behavioral findings in young adults and those with TBI, aphasia, and Alzheimer's disease. From this study team, pilot phosphorous magnetic resonance spectroscopy (31P MRS) and cognitive data in older adults support this mechanism of action and provide compelling evidence for a Phase II clinical trial. To more fully determine whether this novel stimulation approach has potential for enhancing cognition in cognitively normal but "at risk" individuals for Alzheimer's disease, the investigators plan to conduct a multi-site double blinded randomized sham-controlled Phase II clinical trial. The investigators' overall hypothesis is that exposure to NIR stimulation will have beneficial effects on brain health via influence on mitochondrial function as measured by changes in 31P MRS-based markers of ATP, neural network changes in functional connectivity (rs-fMRI), and improved cognitive performance. To test this hypothesis, the study team plans to randomize 168 older adults with subjective cognitive complaints, and a first-degree family history of Alzheimer's disease to sham or real treatment groups and evaluate neuroimaging and cognitive outcome measures, before and after a 12-week intervention involving transcranial and intranasal NIR-PBM. The 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants who meet eligibility criteria will be randomized to the Active or Sham condition. The study biostatistician will randomize participants using a 1:1 allocation scheme with stratification based on age, education, and sex. When a new participant arrives, she/he will be randomized to Active or Sham groups depending on covariate characteristics (age, education, sex) and the cumulative distribution of assignments regarding these variables at that point.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Use of a sham-controlled approach provides stringent experimental control, enabling the investigators to control for placebo/expectations, behavioral activation (engaging in study procedures) and practice effects related to repeated administration of the same cognitive tasks.

The MedX and Vielight devices used for delivery of active and sham NIR stimulation are identical in all respects regarding design, warmth and operation, except that no stimulation is delivered by the sham devices. Because NIR light is invisible, participants will not be able to discern if receiving active or sham stimulation. The participants, interventionists, and outcome assessors will be blinded to the participants' intervention status: Active vs Sham. At completion of the study, all participants will receive a Placebo Control Questionnaire that asks questions pertaining to what group the participant had been assigned. This data will be examined to determine the effectiveness of blinding.

Primary Purpose: Prevention
Condition  ICMJE
  • Cognitive Aging
  • Alzheimer Disease, Protection Against
Intervention  ICMJE
  • Device: Active NIR-PBM
    See Experimental arm for description.
  • Device: Sham NIR-PBM
    See Sham Comparator arm for description.
Study Arms  ICMJE
  • Experimental: Active NIR-PBM

    For transcranial stimulation, the study team will use two MedX units (1116 Rehab Console, MedX Health), whereas intranasal stimulation is delivered using the 810 Intranasal device (Vielight Inc). During each lab session, six transcranial LED clusters will be placed on the scalp in two distinct configurations guided by 10-20 EEG system. Total transcranial stimulation time is 40 minutes, 20 min per cluster. Concurrently, two 810 intranasal devices will be placed in each nostril for 25 min of total dose per nostril. For at home sessions, participants will use the standalone 810 Intranasal device only.

    Total amount of sessions:

    1. 16 sessions of stimulation will occur in the laboratory. Each session will last approximately 90 minutes and will include two 20-minute segments of NIR stimulation.

      AND

    2. 44 sessions of intranasal stimulation in the home. Each session will last 25 minutes and will occur on weekdays when there is no in-lab session.
    Intervention: Device: Active NIR-PBM
  • Sham Comparator: Sham NIR-PBM
    Participants randomized to the Sham control group will undergo identical procedures as the Active group. The only difference is that the "sham" NIR devices are modified not to deliver stimulation. Because NIR is invisible, participants are unable to detect whether NIR is being delivered.
    Intervention: Device: Sham NIR-PBM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2019)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 65-89 years, at least 8th grade education, community dwelling
  • Subjective report of cognitive complaints with scores >16 on the Cognitive Change Index (CCI-20)
  • 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 NACC Uniform Data Set (UDS) norms.
  • 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 1.0 SD (16th %ile) below normative values based on age, education, and gender.
  • Reading at > 8th grade level based on the reading subtest of the Wide Range Achievement Test- IV.
  • Global Clinic Dementia Rating (CDR) score must be 0
  • Family history of dementia/probable Alzheimer's disease in first degree relative (parents, children, siblings)
  • Willingness to be randomized to Sham or Active Intervention
  • Can devote 12 weeks to the intervention with additional time for pre and post testing
  • Normal functional behavior in terms of daily activities, based on the Functional Activities Scale
  • Able to perform cognitive and emotion measures on a computer
  • In line with recommendations of 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.

Exclusion Criteria:

  • Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
  • English as a second language
  • 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
  • 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 TBI, REM Behavior Sleep Disorder, untreated sleep apnea, etc.)
  • Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis.
  • 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.
  • Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
  • Use of prescribed 'memory enhancing' medications such as Aricept or Namenda
  • Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 89 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dawn Bowers, Ph.D. 352-273-6152 dawnbowers@phhp.ufl.edu
Contact: Adam J Woods, Ph.D. 352-294-5842 ajwoods@phhp.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018092
Other Study ID Numbers  ICMJE IRB201901780 -N
R01AG064587 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • University of Arizona
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Dawn Bowers, Ph.D University of Florida
Principal Investigator: Adam J Woods, Ph.D. University of Florida
Principal Investigator: Gene Alexander, Ph.D. University of Arizona
PRS Account University of Florida
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP