Mild Cognitive ImpairmentNCT03192670
A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits
A study testing Low-level light therapy device in people with Mild Cognitive Impairment and Cerebral Blood Flow, run by Yong-il Shin, MD at 2 sites in South Korea.
Trial summary
The primary objective of this study is to confirm and compare the effect of methods of Low-level light therapy (LED-T) in the mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Cerebral Blood Flow, Low-level Light Therapy
- What is being tested?
- Low-level light therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Jun 2017to 31 Dec 2019
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects ages older than 55 years old
- Subjects who has K-MoCA assessment score less than 23
- Subjects who understand the purpose of the study and acquired the consent of the subjects or caregiver
Who cannot join
- Subjects who have K-MMSE less than 19
- Subjects who have pre-existing and present-existing neurological diseases as CNS lesion
- Subjects who have psychiatric disease such as depression, schizophrenia, bipolar disease, or dementia
- Subjects who is estimated as not appropriate for the study by the investigators
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul
Yun-Hee Kim, M.D, Ph.D., 82-2-3410-2824, yun1225.kim@samsung.com
Ahee Lee, 82-2-6007-5408, ahee.lee@gmail.com
Pusan National University Yangsan Hospital Yangsan
Yangsan, Gyeongsangnam-do
About this study
Official title: A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits by Enhancing Cerebral Blow Flow
The primary objective of this study is to confirm and compare the effect of methods of Low-level light therapy (LED-T) in the mild cognitive impairment.
Read the detailed description
Total 168 patients were recruited and randomized to receive either real or sham-LED-T. Real experimental groups were divided into three groups; CA group, VA group, CA+VA dual group. Each group received LED-T (30 min) once a day for 30 days. Each groups LED-T positioned at following locations;
- CA group on the superior border of the thyroid cartilage, and anterior to the sternocleidomastoid muscle based on Korea traditional therapy called Inyoung(ST9)
- VA group on the upper abdomen, spinous process of the 2nd cervical vertebra upper margin based on Korea traditional therapy called CunChu
- CA+VA dual group on the CA position (ST9), and VA position (BL10) The patients were initially evaluated at baseline, immediately, 4wks after intervention.
Study type : Interventional Study Phase : Not provided Study Design : Allocation : Randomized Intervention Model : Parallel Assignment Masking : Single Blind (Investigator) Primary Purpose : Treatment, intervention Condition : Mild cognitive impairment, Health subjects
Intervention :
- Low-level light therapy device (Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter),
- Parameters : Neuroimaging assessement: fMRI, SPECT, Neuropsychological behavioral assessment: SNSB; Seoul Neuropsychological screening battery, K-MoCA, Corsi-block test, K-MBI, K-ADL, GDS, EQ-5D, Neurophysiological assessment: MEP, Motor evoked potential, Gene test(BNDF, ApoE)
Study Arms
- Experimental : Sham control group and real stimulation group.
- In each group, total sessions of the Low-level light therapy (LED-T) was done for intervention was followed after that.
- Subjects received LED-T (30 min) once a day for 30 days.
- The sham control group was kept without LED-T
- Being tested
- Low-level light therapy device
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level light therapy deviceDevice
Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter
| Study group | Role | What they receive |
|---|---|---|
| Sham control group | Sham comparator | Sham control group received same procedure without LED-T. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) Receives: Device: Low-level light therapy device |
| CA(Carotid artery)-stimulation group | Experimental | In CA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that.
Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test.
Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) Receives: Device: Low-level light therapy device |
| VA(Vertebral artery)-stimulation group | Experimental | In VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that.
Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test.
Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) Receives: Device: Low-level light therapy device |
| CA+VA dual stimulation group | Experimental | In CA+VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that.
Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test.
Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) Receives: Device: Low-level light therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Behavioral Assessment 1
SNSB
Measured: Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention
Secondary outcomes (10)
Neuropsychological Behavioral Assessment 2
Corsi-block test
Measured: Baseline, Change from Baseline Corsi-block test at immediately after intervention , Change from Baseline Corsi-block test at 4 weeks after intervention
Neuropsychological Behavioral Assessment 3
K-MoCA
Measured: Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention
ADL assessment 1
K-MBI
Measured: Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention
ADL assessment 2
K-ADL
Measured: Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention
Depression assessment
GDS-SF
Measured: Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention
Quality of Life assessment
EQ-5D
Measured: Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention
Gene test 1
BNDF
Measured: Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention
Gene test 2
ApoE
Measured: Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention
Neuroimaging Assessment 1
fMRI
Measured: Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention
Neuroimaging Assessment 2
SPECT
Measured: Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start20 Jun 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yong-il Shin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center
- Responsible party
- Sponsor-investigator, Yong-il Shin, MD, Pusan National University
- Investigators
- Yong-il Shin, M.D, Ph.D, Study chair, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192670
- Sponsor's protocol ID
- PNUYH-03-2017-003, SMC-2016-1
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee HI, Lee SW, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Low-level light emitting diode therapy promotes long-term functional recovery after experimental stroke in mice. J Biophotonics. 2017 Dec;10(12):1761-1771. doi: 10.1002/jbio.201700038. Epub 2017 May 2.
PubMed 28464523Lee HI, Lee SW, Kim SY, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Pretreatment with light-emitting diode therapy reduces ischemic brain injury in mice through endothelial nitric oxide synthase-dependent mechanisms. Biochem Biophys Res Commun. 2017 May 13;486(4):945-950. doi: 10.1016/j.bbrc.2017.03.131. Epub 2017 Mar 24.
PubMed 28347821Lee HI, Lee SW, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Low-level light emitting diode (LED) therapy suppresses inflammasome-mediated brain damage in experimental ischemic stroke. J Biophotonics. 2017 Nov;10(11):1502-1513. doi: 10.1002/jbio.201600244. Epub 2017 Feb 6.
PubMed 28164443Lee HI, Park JH, Park MY, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Pre-conditioning with transcranial low-level light therapy reduces neuroinflammation and protects blood-brain barrier after focal cerebral ischemia in mice. Restor Neurol Neurosci. 2016;34(2):201-14. doi: 10.3233/RNN-150559.
PubMed 26889965Hong GY, Shin BC, Park SN, Gu YH, Kim NG, Park KJ, Kim SY, Shin YI. Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea. Int J Gynaecol Obstet. 2016 Apr;133(1):37-42. doi: 10.1016/j.ijgo.2015.08.004. Epub 2015 Dec 2.
PubMed 26797192
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Low-level Light Therapy Using Photo-activated Modulation Ameliorates Cognitive Deficits by Enhancing Cerebral Blow Flow
- ClinicalTrials.gov ID
- NCT03192670
- Acronym / sponsor ID
- PNUYH-03-2017-003, SMC-2016-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Yong-il Shin, MDUniversity, hospital or other
- Collaborators
- Samsung Medical Center
- Study start
- 20 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 20 Jun 2017 (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 primary objective of this study is to confirm and compare the effect of methods of Low-level light therapy (LED-T) in the mild cognitive impairment.
Detailed description
Total 168 patients were recruited and randomized to receive either real or sham-LED-T. Real experimental groups were divided into three groups; CA group, VA group, CA+VA dual group. Each group received LED-T (30 min) once a day for 30 days. Each groups LED-T positioned at following locations;
- CA group on the superior border of the thyroid cartilage, and anterior to the sternocleidomastoid muscle based on Korea traditional therapy called Inyoung(ST9)
- VA group on the upper abdomen, spinous process of the 2nd cervical vertebra upper margin based on Korea traditional therapy called CunChu
- CA+VA dual group on the CA position (ST9), and VA position (BL10) The patients were initially evaluated at baseline, immediately, 4wks after intervention.
Study type : Interventional Study Phase : Not provided Study Design : Allocation : Randomized Intervention Model : Parallel Assignment Masking : Single Blind (Investigator) Primary Purpose : Treatment, intervention Condition : Mild cognitive impairment, Health subjects
Intervention :
- Low-level light therapy device (Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter),
- Parameters : Neuroimaging assessement: fMRI, SPECT, Neuropsychological behavioral assessment: SNSB; Seoul Neuropsychological screening battery, K-MoCA, Corsi-block test, K-MBI, K-ADL, GDS, EQ-5D, Neurophysiological assessment: MEP, Motor evoked potential, Gene test(BNDF, ApoE)
Study Arms
- Experimental : Sham control group and real stimulation group.
- In each group, total sessions of the Low-level light therapy (LED-T) was done for intervention was followed after that.
- Subjects received LED-T (30 min) once a day for 30 days.
- The sham control group was kept without LED-T
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham control group | Sham comparator | Device: Low-level light therapy deviceSham control group received same procedure without LED-T. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) |
| CA(Carotid artery)-stimulation group | Experimental | Device: Low-level light therapy deviceIn CA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) |
| VA(Vertebral artery)-stimulation group | Experimental | Device: Low-level light therapy deviceIn VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) |
| CA+VA dual stimulation group | Experimental | Device: Low-level light therapy deviceIn CA+VA group, total sessions of the LED-T was done for each groups and assessment of parameters was followed that. Each group subject underwent LED therapy (30 min) once a day for 20 days, commencing at Baseline screening test. Device: Low-level light therapy device approved by the ethics committees of Pusan National hospital and conformity MSDS as safe treatment device for brain diseases Parameters: Neuroimaging assessment(fMRI, SPECT), Neuropsychological Behavioral Assessment(SNSB, K-MoCA, Corsiblock test, K-MBI, K-ADL, GDS, EQ-5D) |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects ages older than 55 years old
- Subjects who has K-MoCA assessment score less than 23
- Subjects who understand the purpose of the study and acquired the consent of the subjects or caregiver
Key exclusion criteria (4 listed)
- Subjects who have K-MMSE less than 19
- Subjects who have pre-existing and present-existing neurological diseases as CNS lesion
- Subjects who have psychiatric disease such as depression, schizophrenia, bipolar disease, or dementia
- Subjects who is estimated as not appropriate for the study by the investigators
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 |
|---|---|---|
| Low-level light therapy devicePeak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter | Device | CA(Carotid artery)-stimulation group, CA+VA dual stimulation group, Sham control group, VA(Vertebral artery)-stimulation group |
Primary outcome
Neuropsychological Behavioral Assessment 1
Time frame: Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention
SNSB
10 secondary outcomes
Neuropsychological Behavioral Assessment 2
Time frame: Baseline, Change from Baseline Corsi-block test at immediately after intervention , Change from Baseline Corsi-block test at 4 weeks after intervention
Neuropsychological Behavioral Assessment 3
Time frame: Baseline, Change from Baseline K-MoCA at immediately after intervention , Change from Baseline K-MoCA at 4 weeks after intervention
ADL assessment 1
Time frame: Baseline, Change from Baseline K-MBI at immediately after intervention , Change from Baseline K-MBI at 4 weeks after intervention
ADL assessment 2
Time frame: Baseline, Change from Baseline K-ADL at immediately after intervention , Change from Baseline K-ADL at 4 weeks after intervention
Depression assessment
Time frame: Baseline, Change from Baseline GDS-SF at immediately after intervention , Change from Baseline GDS-SF at 4 weeks after intervention
Quality of Life assessment
Time frame: Baseline, Change from Baseline EQ-5D at immediately after intervention , Change from Baseline EQ-5D at 4 weeks after intervention
Gene test 1
Time frame: Baseline, Change from Baseline BNDF at immediately after intervention , Change from Baseline BNDF at 4 weeks after intervention
Gene test 2
Time frame: Baseline, Change from Baseline ApoE at immediately after intervention , Change from Baseline ApoE at 4 weeks after intervention
Neuroimaging Assessment 1
Time frame: Baseline, Change from Baseline fMRI at immediately after intervention , Change from Baseline fMRI at 4 weeks after intervention
Neuroimaging Assessment 2
Time frame: Baseline, Change from Baseline SPECT at immediately after intervention , Change from Baseline SPECT at 4 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Background: PubMed 28464523Lee HI, Lee SW, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Low-level light emitting diode therapy promotes long-term functional recovery after experimental stroke in mice. J Biophotonics. 2017 Dec;10(12):1761-1771. doi: 10.1002/jbio.201700038. Epub 2017 May 2.
- Background: PubMed 28347821Lee HI, Lee SW, Kim SY, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Pretreatment with light-emitting diode therapy reduces ischemic brain injury in mice through endothelial nitric oxide synthase-dependent mechanisms. Biochem Biophys Res Commun. 2017 May 13;486(4):945-950. doi: 10.1016/j.bbrc.2017.03.131. Epub 2017 Mar 24.
- Background: PubMed 28164443Lee HI, Lee SW, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Low-level light emitting diode (LED) therapy suppresses inflammasome-mediated brain damage in experimental ischemic stroke. J Biophotonics. 2017 Nov;10(11):1502-1513. doi: 10.1002/jbio.201600244. Epub 2017 Feb 6.
- Background: PubMed 26889965Lee HI, Park JH, Park MY, Kim NG, Park KJ, Choi BT, Shin YI, Shin HK. Pre-conditioning with transcranial low-level light therapy reduces neuroinflammation and protects blood-brain barrier after focal cerebral ischemia in mice. Restor Neurol Neurosci. 2016;34(2):201-14. doi: 10.3233/RNN-150559.
- Background: PubMed 26797192Hong GY, Shin BC, Park SN, Gu YH, Kim NG, Park KJ, Kim SY, Shin YI. Randomized controlled trial of the efficacy and safety of self-adhesive low-level light therapy in women with primary dysmenorrhea. Int J Gynaecol Obstet. 2016 Apr;133(1):37-42. doi: 10.1016/j.ijgo.2015.08.004. Epub 2015 Dec 2.
- Individual participant dataSharing planned: No
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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.
Yong-il Shin, M.D, Ph.D study chair
Pusan National University Yangsan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level light therapy device in people with Mild Cognitive Impairment and Cerebral Blood Flow, run by Yong-il Shin, MD at 2 sites in South Korea.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong-il Shin, M.D, Ph.D (82-55-2872, rmshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Behavioral Assessment 1 (time frame: Baseline, Change from Baseline SNSB at immediately after intervention , Change from Baseline SNSB at 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192670, which also lists 5 linked publications.
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 20 Jun 2017.