Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
NCT04784416, Phase 2, Completed, NYU Langone Health
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) | ClinicalTrials.gov |
| NCT number | NCT04784416 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 196 participants, actual | ClinicalTrials.gov |
| Lead sponsor | NYU Langone Health | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Alzheimer Disease | ClinicalTrials.gov |
| Interventions | Active tPBM-2.0, Sham tPBM-2.0, 18F-MK-6240 | ClinicalTrials.gov |
| First posted | 2021-03-05 | ClinicalTrials.gov |
| Last updated | 2026-10-29 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. | 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. | ClinicalTrials.gov |
| Secondary | Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. | 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. | ClinicalTrials.gov |
| Secondary | Addenbrooke's Cognitive Examination (ACE-III) Score | 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. | ClinicalTrials.gov |
| Secondary | Addenbrooke's Cognitive Examination (ACE-III) Score | 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. | ClinicalTrials.gov |
| Secondary | Addenbrooke's Cognitive Examination (ACE-III) Score | 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. | ClinicalTrials.gov |
| Secondary | Letter Comparison Test Score | Baseline | The total range of score is 0-21. A higher raw score indicates better performance. | ClinicalTrials.gov |
| Secondary | Letter Comparison Test Score | Week 8 | The total range of score is 0-21. A higher raw score indicates better performance. | ClinicalTrials.gov |
| Secondary | Letter Comparison Test Score | Month 3 | The total range of score is 0-21. A higher raw score indicates better performance. | ClinicalTrials.gov |
| Secondary | Pattern Comparison Test Score | Baseline | The total range of score is 0-30. A higher raw score indicates better performance. | ClinicalTrials.gov |
| Secondary | Pattern Comparison Test Score | Week 8 | The total range of score is 0-30. A higher raw score indicates better performance. | ClinicalTrials.gov |
| Secondary | Pattern Comparison Test Score | Month 3 | The total range of score is 0-30. A higher raw score indicates better performance. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test (SCWT) | 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. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test (SCWT) | 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. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test (SCWT) | 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. | ClinicalTrials.gov |
| Secondary | Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) | 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. | ClinicalTrials.gov |
| Secondary | Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) | 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. | ClinicalTrials.gov |
| Secondary | Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B) | 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. | ClinicalTrials.gov |
| Secondary | TMT-B T-Score | 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 | ClinicalTrials.gov |
| Secondary | TMT-B T-Score | 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 | ClinicalTrials.gov |
| Secondary | TMT-B T-Score | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Face-name Memory Task | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Pattern and Letter Comparison | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)