Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)

Last updated: January 16, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

2

Condition

Mild Cognitive Impairment

Memory Loss

Dementia

Treatment

Sham tPBM-2.0

Active tPBM-2.0

18F-MK-6240

Clinical Study ID

NCT04784416
20-00865
  • Ages 65-85
  • All Genders

Study Summary

This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, ~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to give written informed consent and follow study procedures.

  2. Age > or = 65 years and < or = 85 years.

  3. Meets the Petersen MCI criteria for Amnestic MCI (single and multiple domain) with aClinical Dementia Rating (CDR) between 0.5-1.0, and a Functional Assessment Staging (FAST) of 1-4.

  4. Be willing to identify an informed relative, family member, spouse, or friend forstudy staff to interview to confirm subject reports as per UDS 3.0 guidelines;however the lack of a study informant is not exclusionary.

  5. Have at least a high school diploma/12 years of education.

  6. Participants with current mild MDD may be allowed to participate, given that mildMDD does not affect cognition and does not pose increased risk to the participant,as determined by site PI on a case-by-case basis.

Exclusion

Exclusion Criteria:

  1. Unwilling/unable to comply with study procedures.

  2. Other diagnosis of dementia (i.e. not Alzheimer's type), history of brain tumor, MRIevidence of brain damage or brain disease including significant trauma,hydrocephalus, seizures, intellectual disability, or other serious neurologicaldisorder (e.g. Parkinson's disease or other movement disorders).

  3. History of significant cerebrovascular pathology (e.g., significant stroke).Subjects with a history of cardiovascular disease (e.g., myocardial infarction) willbe allowed to participate at site PI's discretion, on a case-by-case basis, giventhat the cardiovascular disease is stable and does not reflect the presence ofsignificant cerebrovascular pathology.

  4. Clinically unstable systemic medical disorders.

  5. Current DSM-5 diagnosis of alcohol or drug use disorder or other major psychiatricillness (e.g., schizophrenia, bipolar, PTSD, depression). Participants with currentmild MDD may be allowed to participate, given that mild MDD does not affectcognition and does not pose increased risk to the participant, as determined by sitePI on a case-by-case basis. Participants with current moderate/severe MDD will beexcluded.

  6. Clinical or laboratory evidence of hypothyroidism.

  7. Clinically significant abnormal findings of laboratory parameters or at physicalexamination.

  8. Medications affecting cognition (e.g., narcotic analgesics; chronic use ofmedications with anticholinergic activity, anti-Parkinsonian medications,antipsychotic meds, etc.). Stable use (i.e., = 6 months) of memantine oracetylcholinesterase inhibitors will be allowed.

  9. Family history of early onset (<60 y/o) dementia.

  10. Past intolerance or hypersensitivity to t-PBM.

  11. Significant skin conditions on the subject's scalp in the area of the proceduresites.

  12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior tostudy enrollment.

  13. Any type of implants in the head, whose functioning might be affected by t-PBM.

  14. The completion of study imaging procedures is highly encouraged, but not mandatoryfor participants with extenuating circumstances (e.g., having prosthetic devices ormetallic foreign bodies that constitute hazards for MRI, unable to get PET due toprevious level of radiation exposure, having claustrophobia, having a large bodysize and shape).

Study Design

Total Participants: 125
Treatment Group(s): 3
Primary Treatment: Sham tPBM-2.0
Phase: 2
Study Start date:
April 27, 2021
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Nathan Kline Institute

    Orangeburg, New York 10962
    United States

    Active - Recruiting

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