Mild Cognitive ImpairmentPhase 2NCT04784416
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
A Phase 2 study testing Active tPBM-2.0 and 18F-MK-6240 in people with Mild Cognitive Impairment and Alzheimer Disease, run by NYU Langone Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Active tPBM-2.0 and 18F-MK-6240
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2021to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Able to give written informed consent and follow study procedures.
- Age > or = 65 years and < or = 85 years.
- 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.
- 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.
- Have at least a high school diploma/12 years of education.
- 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.
Who cannot join
- Unwilling/unable to comply with study procedures.
- 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).
- 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.
- Clinically unstable systemic medical disorders.
- 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.
- Clinical or laboratory evidence of hypothyroidism.
Show all 14Show fewer
- Clinically significant abnormal findings of laboratory parameters or at physical examination.
- 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.
- Family history of early onset (<60 y/o) dementia.
- Past intolerance or hypersensitivity to t-PBM.
- Significant skin conditions on the subject's scalp in the area of the procedure sites.
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.
- Any type of implants in the head, whose functioning might be affected by t-PBM.
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
NYU Langone Health
New York, New York, 10016
Nathan Kline Institute
Orangeburg, New York, 10962
About this study
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).
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Active tPBM-2.0, Sham tPBM-2.0, 18F-MK-6240
- Keywords
- Transcranial Photobiomodulation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tPBM-2.0Device
The NIR continuous wave (average irradiance = 300 mW/cm2) will be used. The duration or irradiation will be for ~11 minutes (666 seconds).
Sham tPBM-2.0Device
The sham mode (0 mW/cm2) will be used. The duration or sham "irradiation" will be for ~11 minutes (666 seconds).
18F-MK-6240Drug
PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Photobiomodulation (t-PBM) | Experimental | Not described Receives: Device: Active tPBM-2.0; Drug: 18F-MK-6240 |
| Sham | Sham comparator | Not described Receives: Device: Sham tPBM-2.0; Drug: 18F-MK-6240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (26)
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.
Measured: Baseline, Month 3
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.
Measured: 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.
Measured: 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.
Measured: Month 3
Letter Comparison Test Score
The total range of score is 0-21. A higher raw score indicates better performance.
Measured: Baseline
Letter Comparison Test Score
The total range of score is 0-21. A higher raw score indicates better performance.
Measured: Week 8
Letter Comparison Test Score
The total range of score is 0-21. A higher raw score indicates better performance.
Measured: Month 3
Pattern Comparison Test Score
The total range of score is 0-30. A higher raw score indicates better performance.
Measured: Baseline
Pattern Comparison Test Score
The total range of score is 0-30. A higher raw score indicates better performance.
Measured: Week 8
Pattern Comparison Test Score
The total range of score is 0-30. A higher raw score indicates better performance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 3
Letter Number Sequencing Score
this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
Measured: Baseline
Letter Number Sequencing Score
this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
Measured: Week 8
Letter Number Sequencing Score
this study will use T-scores, range = 20 - 80. A higher T-score indicates better performance.
Measured: 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.
Measured: Baseline, up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start27 Apr 2021
- Primary completion30 Oct 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Alzheimer's Association, LiteCure LLC
- Responsible party
- Sponsor
- Investigators
- Dan Iosifescu, MD, Principal investigator, NYU Langone Health and Nathan Kline InstituteRicardo Osorio, MD, Principal investigator, NYU Langone Health and Nathan Kline InstitutePaolo Cassano, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784416
- Sponsor's protocol ID
- 20-00865
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
- ClinicalTrials.gov ID
- NCT04784416
- Acronym / sponsor ID
- 20-00865
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Transcranial Photobiomodulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Alzheimer's Association, LiteCure LLC
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Photobiomodulation (t-PBM) | Experimental | Device: Active tPBM-2.0, Drug: 18F-MK-6240 |
| Sham | Sham comparator | Device: Sham tPBM-2.0, Drug: 18F-MK-6240 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Able to give written informed consent and follow study procedures.
- Age > or = 65 years and < or = 85 years.
- 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.
- 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.
- Have at least a high school diploma/12 years of education.
Key exclusion criteria (14 listed)
- Unwilling/unable to comply with study procedures.
- 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).
- 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.
- Clinically unstable systemic medical disorders.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tPBM-2.0The NIR continuous wave (average irradiance = 300 mW/cm2) will be used. The duration or irradiation will be for ~11 minutes (666 seconds). | Device | Transcranial Photobiomodulation (t-PBM) |
| Sham tPBM-2.0The sham mode (0 mW/cm2) will be used. The duration or sham "irradiation" will be for ~11 minutes (666 seconds). | Device | Sham |
| 18F-MK-6240PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments | Drug | Sham, Transcranial Photobiomodulation (t-PBM) |
Primary outcome
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.
26 secondary outcomes
Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score.
Time frame: Baseline, Month 3
Addenbrooke's Cognitive Examination (ACE-III) Score
Time frame: Baseline
Addenbrooke's Cognitive Examination (ACE-III) Score
Time frame: Week 8
Addenbrooke's Cognitive Examination (ACE-III) Score
Time frame: Month 3
Letter Comparison Test Score
Time frame: Baseline
Letter Comparison Test Score
Time frame: Week 8
Letter Comparison Test Score
Time frame: Month 3
Pattern Comparison Test Score
Time frame: Baseline
Pattern Comparison Test Score
Time frame: Week 8
Pattern Comparison Test Score
Time frame: Month 3
Stroop Color and Word Test (SCWT)
Time frame: Baseline
Stroop Color and Word Test (SCWT)
Time frame: Week 8
Stroop Color and Word Test (SCWT)
Time frame: Month 3
Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B)
Time frame: Baseline
Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B)
Time frame: Week 8
Difference in Score Between Trail Making Test-A (TMT-A) and Trail Making Test-B (TMT-B)
Time frame: Month 3
TMT-B T-Score
Time frame: Baseline
TMT-B T-Score
Time frame: Week 8
TMT-B T-Score
Time frame: Month 3
Face-Name Associative Memory Exam (FNAME-12) Score
Time frame: Baseline
Face-Name Associative Memory Exam (FNAME-12) Score
Time frame: Week 8
Face-Name Associative Memory Exam (FNAME-12) Score
Time frame: Month 3
Letter Number Sequencing Score
Time frame: Baseline
Letter Number Sequencing Score
Time frame: Week 8
Letter Number Sequencing Score
Time frame: Month 3
Change in Systemic Assessment for Treatment Emergent Events - Specific Inquiry (SAFTEE-SI) Score
Time frame: Baseline, up to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be provided upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active tPBM-2.0 and 18F-MK-6240 in people with Mild Cognitive Impairment and Alzheimer Disease, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score. (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.