The Revitalize Study in Older Adults at Risk for Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04018092|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : June 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cognitive Aging Alzheimer Disease, Protection Against||Device: Active NIR-PBM Device: Sham NIR-PBM||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|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)|
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.
|Official Title:||Revitalizing Cognition in Older Adults at Risk for Alzheimer's Disease With Near-Infrared Photobiomodulation|
|Actual Study Start Date :||August 12, 2020|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2024|
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:
Device: Active NIR-PBM
See Experimental arm for description.
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.
Device: Sham NIR-PBM
See Sham Comparator arm for description.
- 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.
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|Ages Eligible for Study:||65 Years to 89 Years (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018092
|Contact: Dawn Bowers, Ph.D.||email@example.com|
|Contact: Adam J Woods, Ph.D.||firstname.lastname@example.org|
|United States, Arizona|
|University of Arizona||Not yet recruiting|
|Tucson, Arizona, United States, 85721|
|United States, Florida|
|University of Florida McKnight Brain Institute||Recruiting|
|Gainesville, Florida, United States, 32610|
|Principal Investigator: Adam J. Woods, PhD|
|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|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
R01AG064587 ( U.S. NIH Grant/Contract )
F31AG071264 ( U.S. NIH Grant/Contract )
|First Posted:||July 12, 2019 Key Record Dates|
|Last Update Posted:||June 30, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
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