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Photobiomodulation
Light Therapy for Alzheimer's Disease
Phase 2
Recruiting
Led By Adam J Woods, Ph.D.
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 65-89 years, at least 8th grade education, community dwelling
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 12
Awards & highlights
Study Summary
This trial will test whether a light therapy intervention can improve brain function in older adults at risk for Alzheimer's disease.
Who is the study for?
This study is for older adults aged 65-89 with subjective cognitive complaints and a family history of Alzheimer's. Participants must have normal cognitive function based on specific tests, be able to perform computer-based tasks, and commit to a 12-week intervention plus testing. An informant must corroborate their daily functioning.Check my eligibility
What is being tested?
The trial is examining the effects of near-infrared (NIR) light therapy on brain health in those at risk for Alzheimer's disease. It involves transcranial and intranasal NIR delivered through LEDs compared against sham treatment over a period of 12 weeks with follow-up.See study design
What are the potential side effects?
Since this trial uses non-invasive NIR light therapy, side effects are expected to be minimal. However, specifics aren't provided in the description; typically such interventions may cause mild discomfort or skin irritation at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 65-89 years old, have completed at least 8th grade, and live in a community.
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My cognitive function tests are within normal range for my age, education, and gender.
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A close family member has had Alzheimer's or dementia.
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I can perform daily activities without any problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Active group ARENA scores compared to Sham group ARENA scores
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active NIR-PBMExperimental Treatment1 Intervention
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:
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
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.
Group II: Sham NIR-PBMPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
University of ArizonaOTHER
514 Previous Clinical Trials
148,103 Total Patients Enrolled
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,537 Total Patients Enrolled
1 Trials studying Cognitive Aging
42 Patients Enrolled for Cognitive Aging
National Institute on Aging (NIA)NIH
1,669 Previous Clinical Trials
28,004,946 Total Patients Enrolled
7 Trials studying Cognitive Aging
659 Patients Enrolled for Cognitive Aging
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You should not have any signs of memory or thinking problems.I have not had major strokes, brain diseases like Parkinson's, or significant brain surgeries.You have participated in a cognitive training study in the last 6 months or are currently involved in another study that includes cognitive or physical activities.I am not taking antipsychotics, sedatives, or medications that heavily affect memory.I am between 65-89 years old, have completed at least 8th grade, and live in a community.I am open to being assigned randomly to a treatment or placebo group.You don't have signs of memory problems or trouble thinking, as shown by a test called the Montreal Cognitive Assessment (MoCA).My cognitive function tests are within normal range for my age, education, and gender.I am taking medication to improve my memory.A close family member has had Alzheimer's or dementia.You have had serious mental health conditions like schizophrenia, bipolar disorder, or severe depression, or have had issues with alcohol or drugs in the past six months.You cannot have a brain scan because you are claustrophobic or have certain metal objects in your body.I haven't used any photo-sensitive medications like steroids or retin-A in the last 15 days.I do not have any severe or uncontrolled health conditions.I do not have significant vision or hearing loss that would prevent me from participating in study tasks.You have reported cognitive problems and scored higher than 16 on a test for cognitive changes.I can perform daily activities without any problems.
Research Study Groups:
This trial has the following groups:- Group 1: Active NIR-PBM
- Group 2: Sham NIR-PBM
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an open call for participants in this experiment?
"According to the website clinicaltrials.gov, this medical trial is actively recruiting volunteers as of June 28th 2022. This study was initially listed on August 12th 2020 and has since been revised multiple times."
Answered by AI
To what extent has enrollment been maximized for this clinical investigation?
"Affirmative. As relayed on clinicaltrials.gov, this medical research is presently recruiting participants; the trial was initially published on August 12th 2020 and has been revised as of June 28th 2022. From two separate centers, 168 people are needed for the study."
Answered by AI
Has the FDA granted access to Active NIR-PBM?
"Taking all available data into account, our team has concluded that Active NIR-PBM is likely to be safe with a score of 2. This determination was based on the fact that this study is in Phase 2 and no efficacy information exists yet."
Answered by AI
What criteria must one meet to be eligible for this medical research?
"This trial is recruiting 168 elderly people, aged between 65 and 89. To be eligible for the study, they must evidence cognitive complaints with a score above 16 on the Cognitive Change Index (CCI-20), have no diagnosis of dementia or mild cognitive impairment as shown by their Montreal Cognitive Assessment (MoCA) results being within normal limits according to NACC Uniform Data Set norms, read at more than an 8th grade level based on Wide Range Achievement Test IV scores, have a Global Clinic Dementia Rating (CDR) score of 0, display psychometric data that does not suggest cognitive impairments when tested via Neuropsychological Battery"
Answered by AI
Does this research encompass individuals aged 35 and above?
"This clinical trial is only open to those aged 65 to 89. There are 23 applicable trials for individuals under 18 and 536 for elderly patients."
Answered by AI
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