Mild Cognitive ImpairmentNCT05596994
7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD
A study testing Lighting Intervention Therapy in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Lighting Intervention Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 30 May 2025
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients must have undergone PET scans to measure amyloid protein accumulation within the past year
- Those taking antidepressants will be included, but type of medicine and dosage intake will be monitored.
- 50 years and older
- Eligible participants will be amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) patients with circadian sleep disturbances who reside in their homes, independent living, or assisted living facilities.
- confirmed amyloid beta positive from an existing ADRC cohort with PET scan (age: 50-85 yrs, 40% M, 60% F; falling between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB)
Who cannot join
- Those taking sleep medication will be not included
- Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- residence in a skilled nursing facility or long-term care
- indication for psychiatric hospitalization or acute suicidality in the opinion of the physician
- recent changes in psychotropics (14 days)
- major organ failure (e.g., kidney failure)
Show all 18Show fewer
- uncontrolled generalized disorders such as hypertension or diabetes
- obstructing cataracts, macular degeneration, and blindness
- o Those who have undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm) will also be excluded
- severe sleep apnea:
- o Apnea will be screened for using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ), a 12-item scale yielding scores between 0 and 60.3. The study will use a score of 29 as a cutoff for men (sensitivity 75%, specificity 65% for sleep apnea), and a cutoff of 26 for women (sensitivity 80%, specificity 67%).
- restless leg syndrome (RLS):
- o RLS will be screened for using the International Restless Legs Scale (IRLS), a 10-item scale that yields scores between 0 and 40.4 The study will use a cutoff of greater than or equal to 11 (indicating the presence of symptoms that are at least moderate) as a positive screen for RLS
- history of:
- severe photosensitivity dermatitis
- severe progressive retinal disease (e.g., macular degeneration), or;
- a permanently dilated pupil (e.g., after certain types of cataract surgery)
- 7T MRI specific exclusions including presence of metallic or biomedical implants (patients can be enrolled at the discretion of the study team and site MRI technicians) and claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Use of 7T Multimodal Imaging to Detect Brain Changes Associated With Light Therapy in Persons With Mild Cognitive Impairment and Mild Alzheimer's Disease
The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. This can be caused by disruption of circadian rhythms and may affect our health and well-being. Circadian rhythms are the natural cycle of physical, mental, and behavior changes that the body goes through in a 24-hour cycle. Circadian rhythms are mostly affected by light and darkness and are controlled by a small area in the middle of the brain. They can affect sleep, body temperature, hormones, appetite, and other body functions. The circadian system plays an important role in the body and can affect sleep and brain function.
The results of the research would help develop light-delivery methods to improve sleep and memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease who typically spend a significant amount of time indoors.
Read the detailed description
Subjects will be enrolled in the study for 26 weeks. During the first week, subject will come in to Mount Sinai for a study visit to complete a few questionnaires about sleep and mood, complete several memory tests and have an MRI of their brain. These study visits will take about 2 hours to complete. During this week, subject will also be asked to wear a wrist actigraph and light meter for 7 days. The actigraph is similar in size to a watch and is used to record their activity and rest patterns, and the light meter measures the amount of light they are exposed to during the day. After the completion of this week, subject will have a light treatment installed in their home that will be in place for 10 weeks. During the last week of the light treatment, subject will again come into Mount Sinai and repeat the questionnaires, memory tests and MRI, and wear the actigraph and light meter. After a 4-week break, subject will again come into Mount Sinai for a third study visit and complete the same questionnaires, memory tests, and MRI, and wear the actigraph and light meter. After this week, subject will have a different type of light treatment installed in their home and left in place for 10 weeks. During the last week of the light treatment, subject will come into Mount Sinai for the final study visit and complete the questionnaires, memory tests and MRI, and wear the actigraph and light meter for 7 days. There are no costs associated with participation, but subject will receive monetary compensation for each of the 4 study visits.
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Lighting Intervention Therapy, Sham LIT
- 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.
Lighting Intervention TherapyDevice
The LIT will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The TLI intervention will remain in place and will be delivered to participants for 10 weeks each in a counterbalanced manner. Combining spectrum and light level, LIT will allow the research team to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The research team will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater) and about 50 lux at the eye during the evening hours (CS of less than 0.1) and when the control lighting intervention is used.
Sham LITDevice
A placebo comparison lighting intervention will be used. The comparison lighting intervention will remain in place and will be delivered to participants for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Light Intervention Therapy (LIT) then Sham LIT | Active comparator | The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT. Receives: Device: Lighting Intervention Therapy; Device: Sham LIT |
| Sham LIT then Light Intervention Therapy | Active comparator | LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm. Receives: Device: Lighting Intervention Therapy; Device: Sham LIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brian Volumes
Volumes of structures associated with cognitive impairment and AD pathophysiology will be quantified from 7T imaging data. Hippocampal subfield volumes and amygdala subnuclei volumes will be computed. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.
Measured: Baseline and post-therapy at Week 26
Changes in Perivascular Space Density
Perivascular spaces will be computed from structural scans using automated segmentation methods. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.
Measured: Baseline and post-therapy at Week 26
Secondary outcomes (8)
Changes in Structural connectivity as measured by dMRI
Diffusion magnetic resonance imaging (dMRI) will be performed. DMRI quantifies the freedom of water molecules to diffuse in various directions, providing information on the microstructural properties of tissues, including diffusivities, fractional anisotropy (FA, the degree to which diffusivity differs with respect to direction, which indicates structural integrity of axons), and the vector along which diffusion is least restricted (which corresponds to the direction of nerve axons in the brain). From these measures, probabilistic streamlines are generated between various brain regions. The number of streamlines connecting two brain regions gives an indication of the degree to which they are connected by axons. Various network theory measures can be generated for each brain region based on a mathematical analysis of its structural connections to other regions. The measures will be compared pre- and post-therapy to determine effect of LIT in the structural connectivity.
Measured: Baseline and post-therapy at Week 26
Changes in Functional connectivity as measured by fMRI
Functional magnetic resonance imaging (fMRI) will be performed. FMRI is sensitive to the amount of deoxygenated blood in a given region of the brain, which varies in response to changes in nerve activation in that region, and in an fMRI experiment, a time series of images is taken over the course of several minutes such that a time-course of neural activation is recorded at each location in the brain In resting-state fMRI, the degree to which the time-course of neural activation in a region of the brain is correlated to the time-course of neural activation in another region of the brain is taken as an indication of the degree to which they are functionally connected. Various network theory measures can be generated for each brain region based on a mathematical analysis of its functional connectivity to other regions. The measures will be compared pre- and post-therapy to determine effect of LIT in the functional connectivity.
Measured: Baseline and post-therapy at Week 26
Percentage of Time Spent in Bed Sleeping
Sleep efficiency will be calculated as the percentage of time spent in bed sleeping using Actigraphy.
Measured: 7 days/week for 26 weeks
Pittsburgh Sleep Quality Index (PSQI) Score
Sleep disturbance using The Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated 19-item questionnaire which assesses sleep quality and disturbances. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall global score ranging from 0 to 21, where lower scores denote a healthier sleep quality, higher score indicates worse sleep quality. A global score >5 is considered to indicate sleep disturbance.
Measured: Baseline and every 4 weeks for duration of the study
Circadian Stimulus (CS) values using the Daysimeter
Light exposure will be measured by the Daysimeter. The instrument will measure photopic light levels (lux) and circadian light levels received by the subject during the day when they are wearing the pendant/pin. This data will then be used to calculate the circadian stimulus (CS) values the subjects are receiving.
Measured: During waking hours for 26 weeks
Changes in Montreal Cognitive Assessment (MoCA) Score
Changes in cognitive status using the Montreal Cognitive Assessment (MoCA). The MoCA is a 1-page, 30-point test that can be administered in 10 minutes. It assesses short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. In a validation study, it was shown to be a promising tool for detecting mild cognitive impairment and early Alzheimer's onset compared to the MMSE. Total scores for MoCA range from 0-30, where higher scores indicate better health outcomes.
Measured: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
Changes Geriatric Depression Scale (GDS) Score
Changes in depression using the GDC Score. The GDS is an instrument used to measure depression in healthy adults. This study will use a short version of the GDS consisting of 15 questions. Ten of the questions indicate the presence of depression when answered positively, and the other five questions indicate depression when answered negatively. Scores of 0-4 = normal, 5-8 = mild depression, 9-11 = moderate depression, and 12-15 = severe depression. Total scale ranges from 0-15, where higher scores indicate more severe depression.
Measured: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
Changes in Dementia Quality of Life Instrument (DQoL) Score
Changes in Quality of Life using the DQoL. The DQoL is designed to assess health-related QoL in persons suffering from dementia. It is administered in interview format, with information obtained exclusively from the elder. The DQoL measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics. The DQoL consists of 29 items, grouped into 5 subscales according to domain. Each of the subscales have a possible range of 1-5, where a higher score indicates better QoL. The subscale scores are not summed for an overall measure of QOL.
Measured: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start28 Feb 2023
- Primary completion30 May 2025
- Study completion30 May 2025
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 Icahn School of Medicine at Mount SinaiThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Priti Balchandani, Icahn School of Medicine at Mount Sinai
- Investigators
- Priti Balchandani, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiMariana Figueiro, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596994
- Sponsor's protocol ID
- GCO 21-0668
- Other IDs
- R21AG076211
- Status last verified
- Jun 2025
- First submitted
- 25 Oct 2022
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot exploratory study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 7T Multimodal Imaging to Detect Brain Changes Associated With Light Therapy in Persons With Mild Cognitive Impairment and Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05596994
- Acronym / sponsor ID
- GCO 21-0668
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Oct 2022 (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.
The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. This can be caused by disruption of circadian rhythms and may affect our health and well-being. Circadian rhythms are the natural cycle of physical, mental, and behavior changes that the body goes through in a 24-hour cycle. Circadian rhythms are mostly affected by light and darkness and are controlled by a small area in the middle of the brain. They can affect sleep, body temperature, hormones, appetite, and other body functions. The circadian system plays an important role in the body and can affect sleep and brain function.
The results of the research would help develop light-delivery methods to improve sleep and memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease who typically spend a significant amount of time indoors.
Detailed description
Subjects will be enrolled in the study for 26 weeks. During the first week, subject will come in to Mount Sinai for a study visit to complete a few questionnaires about sleep and mood, complete several memory tests and have an MRI of their brain. These study visits will take about 2 hours to complete. During this week, subject will also be asked to wear a wrist actigraph and light meter for 7 days. The actigraph is similar in size to a watch and is used to record their activity and rest patterns, and the light meter measures the amount of light they are exposed to during the day. After the completion of this week, subject will have a light treatment installed in their home that will be in place for 10 weeks. During the last week of the light treatment, subject will again come into Mount Sinai and repeat the questionnaires, memory tests and MRI, and wear the actigraph and light meter. After a 4-week break, subject will again come into Mount Sinai for a third study visit and complete the same questionnaires, memory tests, and MRI, and wear the actigraph and light meter. After this week, subject will have a different type of light treatment installed in their home and left in place for 10 weeks. During the last week of the light treatment, subject will come into Mount Sinai for the final study visit and complete the questionnaires, memory tests and MRI, and wear the actigraph and light meter for 7 days. There are no costs associated with participation, but subject will receive monetary compensation for each of the 4 study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light Intervention Therapy (LIT) then Sham LIT | Active comparator | Device: Lighting Intervention Therapy, Device: Sham LITThe LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT. |
| Sham LIT then Light Intervention Therapy | Active comparator | Device: Lighting Intervention Therapy, Device: Sham LITLIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the patients must have undergone PET scans to measure amyloid protein accumulation within the past year
- Those taking antidepressants will be included, but type of medicine and dosage intake will be monitored.
- 50 years and older
- Eligible participants will be amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) patients with circadian sleep disturbances who reside in their homes, independent living, or assisted living facilities.
- confirmed amyloid beta positive from an existing ADRC cohort with PET scan (age: 50-85 yrs, 40% M, 60% F; falling between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB)
Key exclusion criteria (18 listed)
- Those taking sleep medication will be not included
- Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- residence in a skilled nursing facility or long-term care
- indication for psychiatric hospitalization or acute suicidality in the opinion of the physician
- recent changes in psychotropics (14 days)
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 |
|---|---|---|
| Lighting Intervention TherapyThe LIT will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The TLI intervention will remain in place and will be delivered to participants for 10 weeks each in a counterbalanced manner. Combining spectrum and light level, LIT will allow the research team to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The research team will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater) and about 50 lux at the eye during the evening hours (CS of less than 0.1) and when the control lighting intervention is used. | Device | Light Intervention Therapy (LIT) then Sham LIT, Sham LIT then Light Intervention Therapy |
| Sham LITA placebo comparison lighting intervention will be used. The comparison lighting intervention will remain in place and will be delivered to participants for 10 weeks. | Device | Light Intervention Therapy (LIT) then Sham LIT, Sham LIT then Light Intervention Therapy |
Primary outcome
Changes in Brian Volumes
Time frame: Baseline and post-therapy at Week 26
Volumes of structures associated with cognitive impairment and AD pathophysiology will be quantified from 7T imaging data. Hippocampal subfield volumes and amygdala subnuclei volumes will be computed. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.
Changes in Perivascular Space Density
Time frame: Baseline and post-therapy at Week 26
Perivascular spaces will be computed from structural scans using automated segmentation methods. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.
8 secondary outcomes
Changes in Structural connectivity as measured by dMRI
Time frame: Baseline and post-therapy at Week 26
Changes in Functional connectivity as measured by fMRI
Time frame: Baseline and post-therapy at Week 26
Percentage of Time Spent in Bed Sleeping
Time frame: 7 days/week for 26 weeks
Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline and every 4 weeks for duration of the study
Circadian Stimulus (CS) values using the Daysimeter
Time frame: During waking hours for 26 weeks
Changes in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
Changes Geriatric Depression Scale (GDS) Score
Time frame: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
Changes in Dementia Quality of Life Instrument (DQoL) Score
Time frame: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
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 Jun 2025.
- Individual participant dataSharing planned: No. This is a pilot exploratory study.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Priti Balchandani, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Mariana Figueiro, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lighting Intervention Therapy in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site 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 5 inclusion and 18 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 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in Brian Volumes (time frame: Baseline and post-therapy at Week 26). The study lists 2 primary outcomes in all. 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 Jun 2025.