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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Alzheimer's Association | OTHER |
| LiteCure LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Photobiomodulation (t-PBM) | Experimental |
| |
| Sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active tPBM-2.0 | Device | The NIR continuous wave (average irradiance = 300 mW/cm2) will be used. The duration or irradiation will be for ~11 minutes (666 seconds). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. | 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. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. | 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. | Baseline, Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| NYU Langone Health |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access upon reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2025 | Dec 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| Sham tPBM-2.0 | Device | The sham mode (0 mW/cm2) will be used. The duration or sham "irradiation" will be for ~11 minutes (666 seconds). |
|
| 18F-MK-6240 | Drug | PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments |
|
| Addenbrooke's Cognitive Examination (ACE-III) Score |
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. |
| Baseline |
| Addenbrooke's Cognitive Examination (ACE-III) Score | 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. | Week 8 |
| Addenbrooke's Cognitive Examination (ACE-III) Score | 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. | Month 3 |
| Letter Comparison Test Score | The total range of score is 0-21. A higher raw score indicates better performance. | Baseline |
| Letter Comparison Test Score | The total range of score is 0-21. A higher raw score indicates better performance. | Week 8 |
| Letter Comparison Test Score | The total range of score is 0-21. A higher raw score indicates better performance. | Month 3 |
| Pattern Comparison Test Score | The total range of score is 0-30. A higher raw score indicates better performance. | Baseline |
| Pattern Comparison Test Score | The total range of score is 0-30. A higher raw score indicates better performance. | Week 8 |
| Pattern Comparison Test Score | The total range of score is 0-30. A higher raw score indicates better performance. | Month 3 |
| Stroop Color and Word Test (SCWT) | 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. | Baseline |
| Stroop Color and Word Test (SCWT) | 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. | Week 8 |
| Stroop Color and Word Test (SCWT) | 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. | Month 3 |
| Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) | 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. | Baseline |
| Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) | 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. | Week 8 |
| Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) | 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. | Month 3 |
| TMT-B T-Score | 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 | Baseline |
| TMT-B T-Score | 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 | Week 8 |
| TMT-B T-Score | 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 | Month 3 |
| Face-Name Associative Memory Exam (FNAME-12) Score | 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. | Baseline |
| Face-Name Associative Memory Exam (FNAME-12) Score | 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. | Week 8 |
| Face-Name Associative Memory Exam (FNAME-12) Score | 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. | Month 3 |
| Letter Number Sequencing Score | this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance. | Baseline |
| Letter Number Sequencing Score | this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance. | Week 8 |
| Letter Number Sequencing Score | this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance. | Month 3 |
| Change in Systemic Assessment for Treatment Emergent Events - Specific Inquiry (SAFTEE-SI) Score | 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. | Baseline, up to Week 8 |
| New York |
| New York |
| 10016 |
| United States |
| Nathan Kline Institute | Orangeburg | New York | 10962 | United States |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |