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Find more clinical trials

Near-Infrared Light for People at Risk for Alzheimer's Disease

Start: August 12, 2020
End: April 2024
Enrollment: 168

What Is This Study About?

Photobiomodulation is a therapy that uses red or near-infrared light to stimulate tissue that has either been injured or is degenerating. This study will test whether stimulation through the nose and the scalp can enhance cognition in older adults at increased risk for Alzheimer's disease. Participants will be randomly assigned to receive either photobiomodulation or a sham treatment. Over 12 weeks, all participants will attend 16 clinic visits (90 minutes each) to receive treatment and will also complete 44 treatments of intranasal stimulation at home (25 minutes each). Researchers will measure changes in cognition and memory using an online computer test and will assess changes in brain energy use and neural connections with MRI brain scans. All assessments will be done at study start, after 12 weeks, and at a three-month follow-up visit.

Do I Qualify To Participate in This Study?

Minimum Age: 65 Years

Maximum Age: 89 Years

Must have:

  • Family history of dementia and/or probable Alzheimer's disease in a first degree relative (i.e., parents, children, siblings)
  • At least an eighth grade education and reading level, according to the Wide Range Achievement Test-IV
  • No evidence of dementia or mild cognitive impairment based on cognitive screening tests
  • Global Clinic Dementia Rating score must be 0 and Cognitive Change Index score >16
  • Able to commit 12 weeks for the study treatment with additional time before and after for testing
  • Normal functional behavior in daily activities, based on the Functional Activities Scale
  • Able to do tests and other activities on a computer
  • Availability of a study partner to provide information about the participant's cognitive and functional activity

Must NOT have:

  • Sensory loss (e.g., poor vision or hearing) or mobility problems that would interfere with completing study tasks and assessments
  • English as a second language
  • Unable to undergo brain imaging due to claustrophobia or metal implants (e.g., pacemakers, heart valves, brain aneurysm clips, orthodontics, nonremovable body jewelry, or shrapnel) 
  • History of major stroke or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson's disease, multiple sclerosis, seizure disorder, brain surgery, moderate traumatic brain injury, untreated sleep apnea, etc.)
  • Current cancer diagnosis or unstable/uncontrolled medical condition (e.g., moderate-severe kidney disease, severe cardiac disease)
  • Current or history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, major depression)
  • Current alcohol or substance abuse or history within the past six months
  • Use of medications that may influence memory (e.g., donepezil, memantine, antipsychotics, sedatives)
  • Use of light-sensitive medications (e.g., steroids or retin-A) within 15 days of the study treatment
  • Participation in another cognitive training study within the last six months, or planned participation in another study
  • Living in a skilled nursing facility (assisted living facility is acceptable)

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

Study Contact
Dawn Bowers, Ph.D.
Adam J Woods, Ph.D.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
University of Arizona
Tucson, AZ 85721
Not yet recruiting
Florida
University of Florida McKnight Brain Institute
Gainesville, FL 32610
Recruiting
Adam J. Woods, PhD

Who Sponsors This Study?

Lead: University of Florida

Collaborator Sponsor

  • University of Arizona
  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT04018092

alzheimers.gov

An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health