Status:
ACTIVE_NOT_RECRUITING
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institutes of Health (NIH)
Alzheimer's Association
Conditions:
Mild Cognitive Impairment
Alzheimer Disease
Eligibility:
All Genders
65-85 years
Phase:
PHASE2
Brief 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-...
Eligibility Criteria
Inclusion
- Able to give written informed consent and follow study procedures.
- Age \> or = 65 years and \< or = 85 years.
- Meets the Petersen MCI criteria for Amnestic MCI (single and multiple domain) with a Clinical Dementia Rating (CDR) between 0.5-1.0, and a Functional Assessment Staging (FAST) of 1-4.
- Be willing to identify an informed relative, family member, spouse, or friend for study staff to interview to confirm subject reports as per UDS 3.0 guidelines; however the lack of a study informant is not exclusionary.
- Have at least a high school diploma/12 years of education.
- Participants with current mild MDD may be allowed to participate, given that mild MDD 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
- Unwilling/unable to comply with study procedures.
- Other diagnosis of dementia (i.e. not Alzheimer's type), history of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, intellectual disability, or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders).
- History of significant cerebrovascular pathology (e.g., significant stroke). Subjects with a history of cardiovascular disease (e.g., myocardial infarction) will be allowed to participate at site PI's discretion, on a case-by-case basis, given that the cardiovascular disease is stable and does not reflect the presence of significant cerebrovascular pathology.
- Clinically unstable systemic medical disorders.
- Current DSM-5 diagnosis of alcohol or drug use disorder or other major psychiatric illness (e.g., schizophrenia, bipolar, PTSD, depression). Participants with current mild MDD may be allowed to participate, given that mild MDD does not affect cognition and does not pose increased risk to the participant, as determined by site PI on a case-by-case basis. Participants with current moderate/severe MDD will be excluded.
- Clinical or laboratory evidence of hypothyroidism.
- Clinically significant abnormal findings of laboratory parameters or at physical examination.
- Medications affecting cognition (e.g., narcotic analgesics; chronic use of medications with anticholinergic activity, anti-Parkinsonian medications, antipsychotic meds, etc.). Stable use (i.e., = 6 months) of memantine or acetylcholinesterase inhibitors will be allowed.
- Family history of early onset (\<60 y/o) dementia.
- Past intolerance or hypersensitivity to t-PBM.
- Significant skin conditions on the subject's scalp in the area of the procedure sites.
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.
- Any type of implants in the head, whose functioning might be affected by t-PBM.
- The completion of study imaging procedures is highly encouraged, but not mandatory for participants with extenuating circumstances (e.g., having prosthetic devices or metallic foreign bodies that constitute hazards for MRI, unable to get PET due to previous level of radiation exposure, having claustrophobia, having a large body size and shape).
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2026
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04784416
Start Date
April 27 2021
End Date
January 31 2026
Last Update
December 9 2025
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
NYU Langone Health
New York, New York, United States, 10016
3
Nathan Kline Institute
Orangeburg, New York, United States, 10962