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Trial record 1 of 1 for:    TRAP-AD
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Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04784416
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : February 28, 2024
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Alzheimer's Association
LiteCure LLC
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE March 2, 2021
First Posted Date  ICMJE March 5, 2021
Last Update Posted Date February 28, 2024
Actual Study Start Date  ICMJE April 27, 2021
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)		 Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. [ Time Frame: Baseline, Week 8 ]
RBANS is s a brief, individually administered battery to measure cognitive decline or improvement. Total Scale Index Score Range = 40-160. A higher score indicates better performance.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
  • Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. [ Time Frame: Baseline, Month 3 ]
    RBANS is s a brief, individually administered battery to measure cognitive decline or improvement. Total Scale Index Score Range = 40-160. A higher score indicates better performance.
  • Addenbrooke's Cognitive Examination (ACE-III) Score [ Time Frame: Baseline ]
    ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
  • Addenbrooke's Cognitive Examination (ACE-III) Score [ Time Frame: Week 8 ]
    ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
  • Addenbrooke's Cognitive Examination (ACE-III) Score [ Time Frame: Month 3 ]
    ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
  • Letter Comparison Test Score [ Time Frame: Baseline ]
    The total range of score is 0-21. A higher raw score indicates better performance.
  • Letter Comparison Test Score [ Time Frame: Week 8 ]
    The total range of score is 0-21. A higher raw score indicates better performance.
  • Letter Comparison Test Score [ Time Frame: Month 3 ]
    The total range of score is 0-21. A higher raw score indicates better performance.
  • Pattern Comparison Test Score [ Time Frame: Baseline ]
    The total range of score is 0-30. A higher raw score indicates better performance.
  • Pattern Comparison Test Score [ Time Frame: Week 8 ]
    The total range of score is 0-30. A higher raw score indicates better performance.
  • Pattern Comparison Test Score [ Time Frame: Month 3 ]
    The total range of score is 0-30. A higher raw score indicates better performance.
  • Stroop Color and Word Test (SCWT) [ Time Frame: Baseline ]
    SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. This study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Stroop Color and Word Test (SCWT) [ Time Frame: Week 8 ]
    SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. This study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Stroop Color and Word Test (SCWT) [ Time Frame: Month 3 ]
    SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. This study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) [ Time Frame: Baseline ]
    Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time it takes to connect the "trail" is recorded. Reported as B - A. Range = 0 - 100+ (measured in seconds). A higher B - A score indicates poorer performance.
  • Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) [ Time Frame: Week 8 ]
    Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time it takes to connect the "trail" is recorded. Reported as B - A. Range = 0 - 100+ (measured in seconds). A higher B - A score indicates poorer performance.
  • Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) [ Time Frame: Month 3 ]
    TMT is a neuropsychological test of visual attention and task switching. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time it takes to connect the "trail" is recorded. Reported as B - A. Range = 0 - 100+ (measured in seconds). A higher B - A score indicates poorer performance.
  • TMT-B T-Score [ Time Frame: Baseline ]
    In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
  • TMT-B T-Score [ Time Frame: Week 8 ]
    In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
  • TMT-B T-Score [ Time Frame: Month 3 ]
    In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
  • Face-Name Associative Memory Exam (FNAME-12) Score [ Time Frame: Baseline ]
    FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
  • Face-Name Associative Memory Exam (FNAME-12) Score [ Time Frame: Week 8 ]
    FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
  • Face-Name Associative Memory Exam (FNAME-12) Score [ Time Frame: Month 3 ]
    FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
  • Letter Number Sequencing Score [ Time Frame: Baseline ]
    this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Letter Number Sequencing Score [ Time Frame: Week 8 ]
    this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Letter Number Sequencing Score [ Time Frame: Month 3 ]
    this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Change in Systemic Assessment for Treatment Emergent Events - Specific Inquiry (SAFTEE-SI) Score [ Time Frame: Baseline, up to Week 8 ]
    SAFTEE-SI is a list of 55 symptoms. Participants indicate how bothersome each symptom has been for them by circling the appropriate number (0-none, 1-mild, 2-moderate, 3-severe). The total range of score is 0 - 165. The higher the score, the more severely bothersome the symptoms are.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
  • Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. [ Time Frame: Baseline, Month 3 ]
    RBANS is s a brief, individually administered battery to measure cognitive decline or improvement. Total Scale Index Score Range = 40-160. A higher score indicates better performance.
  • Addenbrooke's Cognitive Examination (ACE-III) Score [ Time Frame: Baseline ]
    ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
  • Addenbrooke's Cognitive Examination (ACE-III) Score [ Time Frame: Week 8 ]
    ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
  • Addenbrooke's Cognitive Examination (ACE-III) Score [ Time Frame: Month 3 ]
    ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
  • Letter Comparison Test Score [ Time Frame: Baseline ]
    The total range of score is 0-21. A higher raw score indicates better performance.
  • Letter Comparison Test Score [ Time Frame: Week 8 ]
    The total range of score is 0-21. A higher raw score indicates better performance.
  • Letter Comparison Test Score [ Time Frame: Month 3 ]
    The total range of score is 0-21. A higher raw score indicates better performance.
  • Pattern Comparison Test Score [ Time Frame: Baseline ]
    The total range of score is 0-30. A higher raw score indicates better performance.
  • Pattern Comparison Test Score [ Time Frame: Week 8 ]
    The total range of score is 0-30. A higher raw score indicates better performance.
  • Pattern Comparison Test Score [ Time Frame: Month 3 ]
    The total range of score is 0-30. A higher raw score indicates better performance.
  • Stroop Color and Word Test (SCWT) [ Time Frame: Baseline ]
    SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. This study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Stroop Color and Word Test (SCWT) [ Time Frame: Week 8 ]
    SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. This study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Stroop Color and Word Test (SCWT) [ Time Frame: Month 3 ]
    SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. This study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) [ Time Frame: Baseline ]
    Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Reported as B - A. Range = 0 - 100+ (measured in seconds). A higher B - A score indicates poorer performance.
  • Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) [ Time Frame: Week 8 ]
    Trails Making Test (Trails) is a neuropsychological test of visual attention and task switching. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Reported as B - A. Range = 0 - 100+ (measured in seconds). A higher B - A score indicates poorer performance.
  • Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) [ Time Frame: Month 3 ]
    TMT is a neuropsychological test of visual attention and task switching. Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Reported as B - A. Range = 0 - 100+ (measured in seconds). A higher B - A score indicates poorer performance.
  • TMT-B T-Score [ Time Frame: Baseline ]
    In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
  • TMT-B T-Score [ Time Frame: Week 8 ]
    In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
  • TMT-B T-Score [ Time Frame: Month 3 ]
    In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
  • Face-Name Associative Memory Exam (FNAME-12) Score [ Time Frame: Baseline ]
    FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
  • Face-Name Associative Memory Exam (FNAME-12) Score [ Time Frame: Week 8 ]
    FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
  • Face-Name Associative Memory Exam (FNAME-12) Score [ Time Frame: Month 3 ]
    FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
  • Letter Number Sequencing Score [ Time Frame: Baseline ]
    this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Letter Number Sequencing Score [ Time Frame: Week 8 ]
    this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Letter Number Sequencing Score [ Time Frame: Month 3 ]
    this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
  • Change in Systemic Assessment for Treatment Emergent Events - Specific Inquiry (SAFTEE-SI) Score [ Time Frame: Baseline, up to Week 8 ]
    SAFTEE-SI is a list of 55 symptoms. Participants indicate how bothersome each symptom has been for them by circling the appropriate number (0-none, 1-mild, 2-moderate, 3-severe). The total range of score is 0 - 165. The higher the score, the more severely bothersome the symptoms are.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
Official Title  ICMJE Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
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 65-85) 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Mild Cognitive Impairment
  • Alzheimer Disease
Intervention  ICMJE
  • Device: Active tPBM-2.0
    The NIR continuous wave (average irradiance = 300 mW/cm2) will be used. The duration or irradiation will be for ~11 minutes (666 seconds).
  • 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
Study Arms  ICMJE
  • Experimental: Transcranial Photobiomodulation (t-PBM)
    Interventions:
    • Device: Active tPBM-2.0
    • Drug: 18F-MK-6240
  • Sham Comparator: Sham
    Interventions:
    • Device: Sham tPBM-2.0
    • Drug: 18F-MK-6240
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2021)		 125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.

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 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dan Iosifescu, MD 646-754-5156 dan.iosifescu@nyulangone.org
Contact: Anna Peterson, MA 646-754-2260 anna.peterson@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04784416
Other Study ID Numbers  ICMJE 20-00865
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data will have access upon reasonable request.
Current Responsible Party NYU Langone Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Alzheimer's Association
  • LiteCure LLC
Investigators  ICMJE
Principal Investigator: Dan Iosifescu, MD NYU Langone Health and Nathan Kline Institute
Principal Investigator: Ricardo Osorio, MD NYU Langone Health and Nathan Kline Institute
Principal Investigator: Paolo Cassano, MD, PhD Massachusetts General Hospital
PRS Account NYU Langone Health
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP