Purpose

This study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) (CDR of 0.5-1, FAST 1-3; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At screening, 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). Subjects will also undergo an open label t-PBM session performed during fMRI to detect BOLD changes with t-PBM. Subjects will then be randomized to t-PBM/sham and complete treatments in two participating centers (NYU/NKI acting as a single center, and MGH), ~10 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via pulsed, 808nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3).

Conditions

Eligibility

Eligible Ages
Between 65 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Able to give written informed consent and follow study procedures. 2. Age ≥ 65 years and ≤ 85 years. 3. Meets the Petersen MCI criteria for Amnestic MCI (single and multiple domain) with a Clinical Dementia Rating (CDR) between 0.5 to 1, and a Functional Assessment Staging (FAST) of 1-3. 4. Consents to permit and identifies a willing informed relative, family member, or spouse for study staff to interview to confirm subject reports as per UDS 3.0 guidelines. 5. Have at least a high school diploma / 12 years education

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, 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 cardiovascular or cerebrovascular pathology (e.g., myocardial infarction; stroke). 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). 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. Body size and shape not allowing for a comfortable fit in PET and MRI scanners. 11. Past intolerance or hypersensitivity to t-PBM. 12. Significant skin conditions on the subject's scalp in the area of the procedure sites. 13. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment. 14. Any type of implants in the head, whose functioning might be affected by t-PBM, or any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging. 15. Claustrophobia or metallic foreign bodies that would preclude MRI.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcranial Photobiomodulation (t-PBM)
  • Device: Active tPBM-2.0
    The NIR pulsed wave (irradiance =300 mW/cm2) will be used. The duration or irradiation will be for ~11 minutes (666 seconds).
  • Drug: 18F-MK-6240
    PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments
Sham Comparator
Sham
  • Device: Sham tPBM-2.0
    The sham mode (0 mW/cm2) will be used. The duration or sham "irradiation" will be for ~11 minutes (666 seconds).
  • Drug: 18F-MK-6240
    PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Paolo Cassano, MD, PhD
617-726-6421
PCASSANO@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Dan Iosifescu, MD
646-754-5156
dan.iosifescu@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.