ACTIVE_NOT_RECRUITING

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

Conditions

Mild Cognitive Impairment Alzheimer Disease Transcranial Photobiomodulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-04-27

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04784416

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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 a Clinical 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 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. 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 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.	1. Unwilling/unable to comply with study procedures. 2. 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). 3. 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. 4. Clinically unstable systemic medical disorders. 5. 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. 6. Clinical or laboratory evidence of hypothyroidism. 7. Clinically significant abnormal findings of laboratory parameters or at physical examination. 8. 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. 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 procedure sites. 12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study 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 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).

Inclusion Criteria

Exclusion 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 a Clinical 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 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.
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 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.

1. Unwilling/unable to comply with study procedures.
2. 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).
3. 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.
4. Clinically unstable systemic medical disorders.
5. 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.
6. Clinical or laboratory evidence of hypothyroidism.
7. Clinically significant abnormal findings of laboratory parameters or at physical examination.
8. 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.
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 procedure sites.
12. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study 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 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).

Contacts and Locations

Principal Investigator

Dan Iosifescu, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health and Nathan Kline Institute

Ricardo Osorio, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health and Nathan Kline Institute

Paolo Cassano, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

NYU Langone Health

New York, New York, 10016

United States

Nathan Kline Institute

Orangeburg, New York, 10962

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Dan Iosifescu, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health and Nathan Kline Institute
Ricardo Osorio, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health and Nathan Kline Institute
Paolo Cassano, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-27

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2021-04-27

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Transcranial Photobiomodulation

Additional Relevant MeSH Terms

Mild Cognitive Impairment
Alzheimer Disease