Obstructive Sleep ApneaBrain SCRAPsNCT02474251
Brain Sleep Clearance of Amyloid-Beta Peptides
A study testing Continuous positive airway pressure device in people with Obstructive Sleep Apnea and Alzheimer's Disease, run by NYU Langone Health at 2 sites in United States.
Trial summary
The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the mechanisms involved are not well understood. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Alzheimer's Disease
- What is being tested?
- Continuous positive airway pressure device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2015to 31 Jul 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group A:
- Male and female subjects with normal cognition and 55-75 years of age
- Newly recruited or recruited on the follow-up evaluation from an existing longitudinal cohort of 180 normal elderly already enrolled in an active study (R01HL118624-01).
- Group B:
- Male and female subjects with normal cognition and 30-75 years of age
- Recruited from the MSSM where there are already studies ongoing aimed at determining the consequence of disrupting REM sleep via CPAP withdrawal on the consolidation of spatial navigational memory (PI. Dr. Varga).
Show all 34Show fewer
- Previously diagnosed moderate-severe SDB patients and on active CPAP treatment.
- Group A + B:
- All subjects will be within normal limits on neurological and psychiatric examinations.
- All subjects enrolled will have both a Clinical Dementia Rating (CDR)<0.5 and Global Deterioration Scale (GDS)<3 (i.e. cognitively normal).
- All subjects will have an informed family member or life partner interviewed to confirm the reliability of the subject interview.
- All subjects will agree to the MRI imaging, the lumbar puncture (s), apolipoprotein E (ApoE) genotyping and DNA banking.
- Exclusion Criteria:
- Diagnosis of any brain disease or MRI evidence of brain damage including significant trauma, hydrocephalus, seizures, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders). Persons with silent cortical infarcts will be excluded. White matter lesions will not be exclusions.
- History of brain tumor or contraindications for LP.
- Prior history of post-LP headache.
- Significant history of alcoholism or drug abuse.
- History of major psychiatric illness (e.g., schizophrenia, bipolar or life long history of major depression)
- Geriatric Depression Scale >7 (for subjects > 55 y/o) or Beck Depression Inventory >18 (for subjects <55 y/o)
- Current pregnancy or intent to become pregnant during the period of study.
- Evidence of clinically relevant and uncontrolled cardiac (unstable and untreated coronary or peripheral artery disease), pulmonary (ventilatory failure, Cheyne-Stokes breathing, severe and inadequately controlled arterial hypertension, acute upper respiratory infection), untreated hypothyroid or uncontrolled hematological conditions. Insulin dependent diabetes and/or history of treated hypertension are not exclusions. Normal subjects with current levels of HbA1c >5.9% or diabetics >7.0% and/or current blood pressure levels >140/90 mm Hg will be advised to seek referral.
- Physical impairment of such severity as to adversely affect the validity of psychological testing.
- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- History of a first-degree family member with early onset AD (< age 60) dementia.
- Prior bariatric surgery within 6 months or are currently participating in a medical weight loss program.
- Irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy)
- Inability to avoid the use of alcohol, caffeine during the 48h before the NPSG .
- Patients that are professional vehicle drivers or train operators, or patients that have had a previous motor vehicle accident related to sleepiness and cannot rest the day of the LP after the sleep deprivation experiment.
- Conditions that alter normal sleep patterns: Irregular sleep-wake rhythms (based on one week at home monitoring with actigraphy) or moderate to severe SDB (AHI4%>15 per hour) .
- Medications adversely affecting cognition or sleep will result in exclusion. The excluded medications include:
- Narcotic analgesics (>2 doses per week).
- Chronic use of medications with anticholinergic activity.
- Anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, pergolide, selegeline).
- Others: amphetamines, amphetamine-like compounds, appetite suppressants, phenothiazines, reserpine, buspirone, clonidine, disulfiram, guanethidine, MAO inhibitors, theophylline, tricyclic antidepressants, salicylates, cholinesterase inhibitors and memantine.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hospital Center
New York, New York, 10016
NYU Langone Medical Center
New York, New York, 10016
About this study
The 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ dynamics in the brain are influenced by the sleep-wake cycle, with increases in the production of soluble Aβ during wakefulness and decreases during non-rapid eye movement (NREM) sleep, and more specifically on NREM stage 3 (also called slow wave sleep [SWS]). These changes produce a consistent diurnal pattern in the cerebrospinal fluid (CSF) that has been documented in murine models and in humans. By better understanding this sleep-wake relationship the investigators hope to identify how sleep disorders accelerate the progression of AD in the elderly (which has been demonstrated by multiple epidemiological studies) and, in turn, identify novel therapeutic targets for AD prevention.
The purpose of this study is to elucidate how soluble amyloid beta (Aβ) levels in the brain are influenced by the sleep-wake cycle in humans, and to test the directionality of this relationship through sleep disruption experiments. The investigators will test two models. The first model will test how, prior to amyloid deposition, brain soluble Aβ levels may be relatively increased in the elderly by two mechanisms: a) loss of total sleep time and SWS that occur with normal aging; and b) sleep disturbances such as Sleep Disordered Breathing (SDB) or insomnia that are common in late life (Aim 1). The second model will test how stage-specific sleep disruption may lead to increased CSF Aβ42 levels (Aim 2). A group of adults with diagnosed severe SDB and good continuous positive airway pressure (CPAP) compliance will be used to test this model sleep deprivation experiments using therapeutic CPAP vs. sham CPAP.
This project will be the first to explore the protective effect of SWS on Aβ42 dynamics in a group of cognitively normal elderly subjects as well as the effect of acute sleep disruption by CPAP withdrawal on CSF Aβ42 levels in a well characterized clinical sample of severe obstructive SDB patients on treatment with CPAP. The results from this study will improve our understanding of the nature of the Aβ diurnal pattern and the brain consequences of full night sleep disruptions as well as sleep disruptions during specific stages of sleep.
Read the detailed description
Evaluations and procedures performed by the participants in:
Aim 1 Subjects were newly enrolled normal elderly or normal elderly recruited from R01HL118624-01 and evaluated according to the studies protocol.
Visit 1: During this visit, participants will undergo a complete physical exam, neurological examination, psychiatric interview, sleep interview, neuropsychological testing, Heart testing (EKG), laboratory analysis of blood. (90cc)
Visit 2: During this visit, participants will undergo an MRI scan and be educated on completing home monitoring of sleep wake cycle with actigraphy.
Visit 3: Patients will receive one FBB PET/MR scan to establish amyloid status.
Visit 4: Patients will undergo one night of NPSG with maze task prior to the subjects' scheduled morning LP with collection of CSF (15 cc).
Aim 2 All subjects will receive a complete evaluation (outlined below). Visit 1 and visit 2 will be used to screen subjects for inclusion.
Visit 1: During this visit participant will undergo a complete physical exam, neurological examination, psychiatric interview, sleep interview, psychometric testing, heart testing (EKG), laboratory analysis of blood. (90cc)
Visit 2: During this visit patient will undergo an MRI scan and be educated on completing home monitoring of sleep wake cycle with actigraphy.
Visit 3: Patients will undergo one night of NPSG at MSSM with either consistent use of CPAP or use of Sham CPAP to model discontinuation. Approximately, 10 hours after sleep onset participant will have a LP with collection of CSF. They will also complete 3D Visual Maze task the night of in lab assessment and the morning after, right before the LP (15 cc).
Visit 4: Patients will undergo one night of NSPG at MSSM with either consistent use of CPAP or use of Sham CPAP to model discontinuation. Approximately, 10 hours after sleep onset participant will have a LP with collection of CSF. They will also complete 3D Visual Maze task the night of in lab assessment and the morning after, right before the LP (15 cc)
Incidental findings from study procedures (except for CSF analyses and ApoE genotyping) will be communicated to study subjects by the Study Physician.
- Conditions
- Obstructive Sleep Apnea, Alzheimer's Disease
- Being tested
- Continuous positive airway pressure device
- Medical subject headings
- Sleep Apnea, Obstructive, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure deviceOther
Also called CPAP
GROUP B ONLY will be evaluated on two randomized counterbalanced nights, on one they will undergo a full night of therapeutic CPAP; on the other the investigators will withdraw CPAP during SWS only. A morning LP will be performed approximately 10 hours after sleep onset in both visits
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 25 cognitively normal elderly subjects (age 55-75), newly enrolled or currently participating in R01HL118624-01 (IRB S12-03068), a 2-year longitudinal on-going study that is aimed at examining the longitudinal associations between SDB and cognitive decline in the elderly. Receives: Other: Continuous positive airway pressure device |
| Group B | Active comparator | 20 cognitively normal adults (age 30-75) with severe SDB (Apnea Hypopnea index [AHI]-all >30/hour) and good CPAP compliance from Mt. Sinai School of Medicnie (MSSM) Receives: Other: Continuous positive airway pressure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Aβ42/Aβ40 levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 May 2017
- Study completion31 Jul 2019
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 Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ricardo Osorio, MD, Principal investigator, NYU MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474251
- Sponsor's protocol ID
- 14-01837
- Other IDs
- 5R21AG049348-02
- Acronym
- Brain SCRAPs
- Status last verified
- Jul 2020
- First submitted
- 15 Jun 2015
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hardy JA, Higgins GA. Alzheimer's disease: the amyloid cascade hypothesis. Science. 1992 Apr 10;256(5054):184-5. doi: 10.1126/science.1566067. No abstract available.
PubMed 1566067Kang JE, Lim MM, Bateman RJ, Lee JJ, Smyth LP, Cirrito JR, Fujiki N, Nishino S, Holtzman DM. Amyloid-beta dynamics are regulated by orexin and the sleep-wake cycle. Science. 2009 Nov 13;326(5955):1005-7. doi: 10.1126/science.1180962. Epub 2009 Sep 24.
PubMed 19779148Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
PubMed 24136970Lucey BP, Bateman RJ. Amyloid-beta diurnal pattern: possible role of sleep in Alzheimer's disease pathogenesis. Neurobiol Aging. 2014 Sep;35 Suppl 2:S29-34. doi: 10.1016/j.neurobiolaging.2014.03.035. Epub 2014 May 15.
PubMed 24910393Bayer-Carter JL, Green PS, Montine TJ, VanFossen B, Baker LD, Watson GS, Bonner LM, Callaghan M, Leverenz JB, Walter BK, Tsai E, Plymate SR, Postupna N, Wilkinson CW, Zhang J, Lampe J, Kahn SE, Craft S. Diet intervention and cerebrospinal fluid biomarkers in amnestic mild cognitive impairment. Arch Neurol. 2011 Jun;68(6):743-52. doi: 10.1001/archneurol.2011.125.
PubMed 21670398
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Sleep Clearance of Amyloid-Beta Peptides
- ClinicalTrials.gov ID
- NCT02474251
- Acronym / sponsor ID
- Brain SCRAPs / 14-01837
- Conditions
- Obstructive Sleep Apnea, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 Jun 2015 (estimated)
- 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 'Amyloid Cascade Hypothesis' posits that the accumulation of a peptide, amyloid beta (Aβ), in the brain is the initiating event in Alzheimer's disease (AD), however, the mechanisms involved are not well understood. Recent studies support the hypothesis that Aβ dynamics in the brain are influenced by the sleep-wake cycle, with increases in the production of soluble Aβ during wakefulness and decreases during non-rapid eye movement (NREM) sleep, and more specifically on NREM stage 3 (also called slow wave sleep [SWS]). These changes produce a consistent diurnal pattern in the cerebrospinal fluid (CSF) that has been documented in murine models and in humans. By better understanding this sleep-wake relationship the investigators hope to identify how sleep disorders accelerate the progression of AD in the elderly (which has been demonstrated by multiple epidemiological studies) and, in turn, identify novel therapeutic targets for AD prevention.
The purpose of this study is to elucidate how soluble amyloid beta (Aβ) levels in the brain are influenced by the sleep-wake cycle in humans, and to test the directionality of this relationship through sleep disruption experiments. The investigators will test two models. The first model will test how, prior to amyloid deposition, brain soluble Aβ levels may be relatively increased in the elderly by two mechanisms: a) loss of total sleep time and SWS that occur with normal aging; and b) sleep disturbances such as Sleep Disordered Breathing (SDB) or insomnia that are common in late life (Aim 1). The second model will test how stage-specific sleep disruption may lead to increased CSF Aβ42 levels (Aim 2). A group of adults with diagnosed severe SDB and good continuous positive airway pressure (CPAP) compliance will be used to test this model sleep deprivation experiments using therapeutic CPAP vs. sham CPAP.
This project will be the first to explore the protective effect of SWS on Aβ42 dynamics in a group of cognitively normal elderly subjects as well as the effect of acute sleep disruption by CPAP withdrawal on CSF Aβ42 levels in a well characterized clinical sample of severe obstructive SDB patients on treatment with CPAP. The results from this study will improve our understanding of the nature of the Aβ diurnal pattern and the brain consequences of full night sleep disruptions as well as sleep disruptions during specific stages of sleep.
Detailed description
Evaluations and procedures performed by the participants in:
Aim 1 Subjects were newly enrolled normal elderly or normal elderly recruited from R01HL118624-01 and evaluated according to the studies protocol.
Visit 1: During this visit, participants will undergo a complete physical exam, neurological examination, psychiatric interview, sleep interview, neuropsychological testing, Heart testing (EKG), laboratory analysis of blood. (90cc)
Visit 2: During this visit, participants will undergo an MRI scan and be educated on completing home monitoring of sleep wake cycle with actigraphy.
Visit 3: Patients will receive one FBB PET/MR scan to establish amyloid status.
Visit 4: Patients will undergo one night of NPSG with maze task prior to the subjects' scheduled morning LP with collection of CSF (15 cc).
Aim 2 All subjects will receive a complete evaluation (outlined below). Visit 1 and visit 2 will be used to screen subjects for inclusion.
Visit 1: During this visit participant will undergo a complete physical exam, neurological examination, psychiatric interview, sleep interview, psychometric testing, heart testing (EKG), laboratory analysis of blood. (90cc)
Visit 2: During this visit patient will undergo an MRI scan and be educated on completing home monitoring of sleep wake cycle with actigraphy.
Visit 3: Patients will undergo one night of NPSG at MSSM with either consistent use of CPAP or use of Sham CPAP to model discontinuation. Approximately, 10 hours after sleep onset participant will have a LP with collection of CSF. They will also complete 3D Visual Maze task the night of in lab assessment and the morning after, right before the LP (15 cc).
Visit 4: Patients will undergo one night of NSPG at MSSM with either consistent use of CPAP or use of Sham CPAP to model discontinuation. Approximately, 10 hours after sleep onset participant will have a LP with collection of CSF. They will also complete 3D Visual Maze task the night of in lab assessment and the morning after, right before the LP (15 cc)
Incidental findings from study procedures (except for CSF analyses and ApoE genotyping) will be communicated to study subjects by the Study Physician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Continuous positive airway pressure device25 cognitively normal elderly subjects (age 55-75), newly enrolled or currently participating in R01HL118624-01 (IRB S12-03068), a 2-year longitudinal on-going study that is aimed at examining the longitudinal associations between SDB and cognitive decline in the elderly. |
| Group B | Active comparator | Other: Continuous positive airway pressure device20 cognitively normal adults (age 30-75) with severe SDB (Apnea Hypopnea index [AHI]-all >30/hour) and good CPAP compliance from Mt. Sinai School of Medicnie (MSSM) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Male and female subjects with normal cognition and 55-75 years of age
- Newly recruited or recruited on the follow-up evaluation from an existing longitudinal cohort of 180 normal elderly already enrolled in an active study (R01HL118624-01).
- Male and female subjects with normal cognition and 30-75 years of age
- Recruited from the MSSM where there are already studies ongoing aimed at determining the consequence of disrupting REM sleep via CPAP withdrawal on the consolidation of spatial navigational memory (PI. Dr. Varga).
- Previously diagnosed moderate-severe SDB patients and on active CPAP treatment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Continuous positive airway pressure deviceAlso: CPAPGROUP B ONLY will be evaluated on two randomized counterbalanced nights, on one they will undergo a full night of therapeutic CPAP; on the other the investigators will withdraw CPAP during SWS only. A morning LP will be performed approximately 10 hours after sleep onset in both visits | Other | Group A, Group B |
Primary outcome
CSF Aβ42/Aβ40 levels
Time frame: 6 months
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 24 Jul 2020.
- Background: PubMed 1566067Hardy JA, Higgins GA. Alzheimer's disease: the amyloid cascade hypothesis. Science. 1992 Apr 10;256(5054):184-5. doi: 10.1126/science.1566067. No abstract available.
- Background: PubMed 19779148Kang JE, Lim MM, Bateman RJ, Lee JJ, Smyth LP, Cirrito JR, Fujiki N, Nishino S, Holtzman DM. Amyloid-beta dynamics are regulated by orexin and the sleep-wake cycle. Science. 2009 Nov 13;326(5955):1005-7. doi: 10.1126/science.1180962. Epub 2009 Sep 24.
- Background: PubMed 24136970Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.
- Background: PubMed 24910393Lucey BP, Bateman RJ. Amyloid-beta diurnal pattern: possible role of sleep in Alzheimer's disease pathogenesis. Neurobiol Aging. 2014 Sep;35 Suppl 2:S29-34. doi: 10.1016/j.neurobiolaging.2014.03.035. Epub 2014 May 15.
- Background: PubMed 21670398Bayer-Carter JL, Green PS, Montine TJ, VanFossen B, Baker LD, Watson GS, Bonner LM, Callaghan M, Leverenz JB, Walter BK, Tsai E, Plymate SR, Postupna N, Wilkinson CW, Zhang J, Lampe J, Kahn SE, Craft S. Diet intervention and cerebrospinal fluid biomarkers in amnestic mild cognitive impairment. Arch Neurol. 2011 Jun;68(6):743-52. doi: 10.1001/archneurol.2011.125.
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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.
Ricardo Osorio, MD principal investigator
NYU MEDICAL CENTER
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure device in people with Obstructive Sleep Apnea and Alzheimer's Disease, run by NYU Langone Health at 2 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 34 inclusion and 0 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 24 Jul 2020. 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 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?
CSF Aβ42/Aβ40 levels (time frame: 6 months). 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 NCT02474251, 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 24 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.