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Anaplastic AstrocytomaPhase 2NCT03180502

Proton Beam or Intensity-Modulated Radiation Therapy in Preserving Brain Function in Patients With IDH Mutant Grade II or III Glioma

A Phase 2 study testing Biospecimen Collection, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma, run by NRG Oncology at 34 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
34 sitesUnited States
Study dates
23 Jan 2018to 13 Jul 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRIOR TO STEP 1 REGISTRATION
  • Tumor tissue must be available for submission for central pathology review
  • Grade II and III gliomas IDH mutant gliomas including; diffuse astrocytoma, anaplastic astrocytoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytoma, anaplastic oligoastrocytoma
  • Documentation from the enrolling site confirming the presence of IDH mutation and 1p/19q status; the provided information must document assays performed in clinical laboratory improvement amendments (CLIA)-approved laboratories and be uploaded prior to Step 2 registration
  • Age >= 18
  • The trial is open to both genders
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  • Only English or French speaking patients are eligible to participate as the cognitive assessments are only available in these languages
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • History and physical exam, and Karnofsky performance status of >= 70 within 30 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 60 days prior to registration)
  • Platelets >= 100,000 cells/mm^3 (within 60 days prior to registration)
  • Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (within 60 days prior to registration)
  • Bilirubin =< 1.5 upper limit of normal (ULN) (within 60 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within 60 days prior to registration)
  • Blood urea nitrogen (BUN) < 30 mg/dl (within 60 days prior to registration)
  • Serum creatinine < 1.5 mg/dl (within 60 days prior to registration)
  • Pre-operative MRI imaging of the brain available for radiation planning
  • Post-operative MRI imaging with contrast is mandatory obtained for radiation therapy planning; enrolling sites are not mandated although highly encouraged to obtain thin-slice (< 1.5 mm) 3 dimensional (D) pre and post contrast and axial T2/FLAIR sequences for planning purposes
  • Patients must be able to swallow capsules
  • PRIOR TO STEP 2 REGISTRATION
  • Histologically proven diagnosis of supratentorial, World Health Organization (WHO) grade II or III astrocytoma, oligodendroglioma or oligoastrocytoma, with IDH mutation confirmed by central review
  • The following baseline neurocognitive assessments must be completed and uploaded prior to Step 2 registration: HVLT-R (recall, delayed recall, and recognition), TMT Parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidata RAVE System for central evaluation; once the upload and scoring of the tools are complete, a notification will be sent within 3 business days to the Research Associate (RA) to proceed to Step 2; in order for the patient to be eligible, at least 5 of the 6 neurocognitive assessments must be able to be scored (i.e. free of any errors)
  • Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step 2 registration
  • Financial clearance for proton therapy treatment prior step 2 registration
  • Women of childbearing age must have a negative serum pregnancy test within 14 days prior to step 2 registration

Who cannot join

  • Definitive clinical or radiologic evidence of metastatic disease; if applicable
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; (for example, carcinoma in situ of the breast, oral cavity or cervix are permissible)
  • Prior cranial radiotherapy or radiotherapy to the head and neck where potential field overlaps would exist
  • Prior chemotherapy or radiotherapy for any brain tumor
  • Histologic diagnosis of glioblastoma (WHO grade IV) or pilocytic astrocytoma (WHO grade I)
  • Definitive evidence of multifocal disease
Show all 26Show fewer
  • Planned use of cytotoxic chemotherapy during radiation (only adjuvant temozolomide therapy will be used on this protocol)
  • Patients with infra-tentorial tumors are not eligible
  • Prior history of neurologic or psychiatric disease believed to impact cognitive function
  • The use of memantine during or following radiation is NOT allowed
  • Severe, active co-morbidity defined as follows:
  • Unstable angina or congestive heart failure requiring hospitalization within 6 months prior to enrollment
  • Transmural myocardial infarction within the last 6 months prior to registration; evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed within 28 days prior to registration (Note: EKG to be performed only if clinical suspicion of cardiac issue)
  • New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
  • Serious and inadequately controlled arrhythmia at step 2 registration
  • Serious or non-healing wound, ulcer or bone fracture or history of abdominal fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for surgical resection
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol
  • Any other severe immunocompromised condition
  • Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
  • End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
  • Any other major medical illnesses or psychiatric treatments that in the investigator's opinion will prevent administration or completion of protocol therapy
  • Inability to undergo MRI with and without contrast (e.g. claustrophobia, non-MRI compatible implant or foreign body, gadolinium allergy or renal dysfunction preventing the patient from receiving gadolinium- institutional guidelines should be used to determine if patients are at risk for renal dysfunction); note that patients with severe claustrophobia are permitted on this study if they are willing and able to undergo MRI with adequate sedation or anesthesia
  • Patients known to have hypersensitivity to dacarbazine (DTIC) are not eligible

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Northwestern University

    Chicago, Illinois, 60611

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • FHCC at Northwest Hospital

    Seattle, Washington, 98133

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas

This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. It is not yet known if proton beam radiation therapy is more effective than photon-based beam intensity-modulated radiation therapy in treating patients with glioma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether proton therapy, compared to intensity-modulated radiation therapy (IMRT), preserves cognitive outcomes over time as measured by the Clinical Trial Battery Composite (CTB COMP) score (calculated from the Hopkins Verbal Learning Test Revised [HVLT-R]) Total Recall, HVLT-R Delayed Recall, HVLT-R Delayed Recognition, Controlled Oral Word Association (COWA) test, Trail Making Test (TMT) part A and part B.

SECONDARY OBJECTIVES:

  1. To assess whether treatment with proton therapy preserves neurocognitive function as measured separately by each test, HVLT-R, TMT parts A \& B, and COWA.

II. To document and compare treatment related symptoms, overall symptom impact, and disease related factor groupings, utilizing the M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT), for both treatment arms.

III. To assess whether treatment with proton therapy, compared to IMRT, results in superior quality of life as measured by the Linear Analog Scale Assessment (LASA) scale.

IV. To compare local control patterns of failure and overall and progression-free survival between the two treatment arms.

  1. To assess adverse events. VI. To compare Illumnia MethylationEPIC beadchip array-derived IDH and 1p19q status determined centrally to that submitted by enrolling sites.

TERTIARY OBJECTIVES:

  1. To assess the impact of chemotherapy use on cognitive outcomes, symptom outcomes and quality of life.

II. To assess dose-response relationships between neuro-anatomic dosimetry and cognitive outcomes within and between treatment arms.

III. To evaluate the association between tumor molecular status and cognition at baseline and within and between treatment arms over time.

IV. To assess patterns of failure and pseudo progression as a function of radiation delivery type and dose received.

  1. To assess local control, overall survival and, progression free survival in IDH mutant grade II and III tumors.

VI. To collect blood samples for future studies seeking to correlate changes in peripheral blood biomarkers (genes, micro ribonucleic acid [RNA], proteins, lymphocyte count, melatonin, etc) and the study endpoints.

VII. To document and compare the impact of low to intermediate gliomas and therapy on patients' work and activity participation (The Work Productivity and Activity Impairment [WPAI:GH] Questionnaire: General Health version 2.0) as well as the relationship between changes in patients' work and activity participation and neurocognitive function and patient reported symptoms and interference.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo photon-based IMRT once daily (QD), 5 days a week for 6 weeks for a total of 30 fractions. Beginning 28 days after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.

ARM II: Patients undergo proton beam radiation therapy QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 28 days after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity. Patients undergo MRI and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up at 6 and 12 months and then yearly for 10 years.

Being tested
Biospecimen Collection, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Proton Beam Radiation Therapy
Medical subject headings
Astrocytoma, Oligodendroglioma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Proton Beam Radiation TherapyRadiation

    Also called External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton

    Undergo proton beam radiation therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • TemozolomideDrug

    Also called CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831

    Drug

Study groups in NCT03180502
Study groupRoleWhat they receive
Arm I (photon-based IMRT, temozolomide)Active comparatorPatients undergo photon-based IMRT QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 28 days after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity. Patients undergo MRI and collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide
Arm II (proton beam radiation therapy, temozolomide)ExperimentalPatients undergo proton beam radiation therapy QD, 5 days a week for 6 weeks for a total of 30 fractions. Beginning 28 days after completion of radiation therapy, patients receive standard of care temozolomide for 5 days. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression of unacceptable toxicity. Patients undergo MRI and collection of blood samples throughout the trial.
Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognition as measured by the Clinical Trial Battery Composite (CTB COMP) score

    Assessed with a general linear model with maximum likelihood estimation. Three models will be conducted. Baseline CTB COMP score, treatment arm, time, treatment by time interaction (if significant) and stratification factors will be included in the model for the primary endpoint. A second model will be built with these same variables and relevant covariates, such as total volume of intracranial disease, gross tumor volume (GTV) and clinical tumor volume (CTV) size, histology, anti-epileptic use, and disease response to therapy (as measured by Response Assessment in Neuro-Oncology [RANO] criteria). Other than baseline score CTB COMP, treatment arm, and time, only covariates with a p-value < 0.10 will be retained in the model. A third model will be conducted at 10 years using the additional time points of neurocognitive assessments.

    Measured: Baseline to up to 10 years

Secondary outcomes (8)

  1. Cognition as measured individually by Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test (TMT) parts A and B, and Controlled Oral Word Association (COWA)

    The HVLT-R, TMT parts A \& B, and COWA will be analyzed independently using a general linear model with maximum likelihood estimation. Standardized scores will be used.

    Measured: Up to 10 years

  2. Change in symptoms as measured by M.D. Anderson Symptom Inventory Brain Tumor (MDASI-BT)

    The change from baseline to each follow-up time point (calculated as baseline score subtracted from follow-up score) will be compared between treatment arms using a t-test, or Wilcoxon test if the data is not normally distributed. A reduced one-sided significance level will be used for the multiple comparisons in the MDASI-BT using the Bonferroni adjustment (alpha=0.017 for disease related factors and alpha=0.025 for treatment related symptoms and overall impact). A general linear model with maximum likelihood estimation will be used to assess symptom trends across time. Baseline score, treatment arm, time, treatment by time interaction (if significant), stratification factors, and relevant covariates, such as total volume of, GTV and CTV size, histology, anti-epileptic use, and disease response to therapy (as measured by RANO criteria) will be included as covariates in each model.

    Measured: Baseline to up to 10 years

  3. Change in quality of life as measured by the Linear Analog Scale Assessment (LASA) scale

    The change from baseline to each follow-up time point (calculated as baseline score subtracted from follow-up score) will be compared between treatment arms using a t-test, or Wilcoxon test if the data is not normally distributed. A one-sided alpha=0.05 will be used for the LASA. A general linear model with maximum likelihood estimation will be used to assess symptom and QOL trends across time. Baseline score, treatment arm, time, treatment by time interaction (if significant), stratification factors, and relevant covariates, such as total volume of, GTV and CTV size, histology, anti-epileptic use, and disease response to therapy (as measured by RANO criteria) will be included as covariates in each model. Other than baseline score, treatment arm, and time, only covariates with a p-value < 0.10 will be retained in the model.

    Measured: Up to 10 years

  4. Overall survival (OS)

    OS will be estimated using the Kaplan-Meier method and compared between arms using the log rank test. Cox proportional hazards models will be used for OS adjusting for treatment arm and stratification factors.

    Measured: From randomization to the date of death, assessed up to 10 years

  5. Local control as assessed by Response Assessment in Neuro-Oncology (RANO) criteria

    Local control will be estimated using cumulative incidence, treating death prior to an event as a competing risk. Gray's test will be used to compare local control rates between arms. Cause-specific Cox proportional hazards models will be used for local control, adjusting for treatment arm and stratification factors. A two-sided significance level of 0.05 will be used for comparisons between arms.

    Measured: Up to 10 years

  6. Progression-free survival (PFS)

    A confidence interval will be used to determine if the PFS rate in the proton arm is greater than that in the photon at 1 year. PFS will be estimated using the Kaplan-Meier method and compared between arms using the log rank test. Cox proportional hazards models will be used for PFS adjusting for treatment arm and stratification factors.

    Measured: From date of randomization to date of progression or death, whichever occurs first, assessed up to 10 years

  7. Incidence of adverse events (AEs) graded according to the National Cancer Institute's Common Terminology for Adverse Events version 5.0

    Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. Grade 3+ treatment related AEs will be compared between arms using a chi-square test, or Fisher's exact test if cell frequencies are < 5, at the one-sided 0.05 significance level.

    Measured: Up to 10 years

  8. IDH mutation as assessed by sequencing and 1p19q status as assessed by fluorescence in situ hybridization

    A single test will be done for both IDH and 1p19q testing centrally while sites will perform a separate test for IDH and 1p19q. The results from the central and site testing will be compared using the kappa statistic. The asymptotic test of H0: k=0 will be performed using the Z-statistic to determine the strength of agreement. Concordance and discordance rates will be tabulated.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2017
  2. Study start23 Jan 2018
  3. Primary completion13 Jul 2026
  4. Study completion13 Jul 2031 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180502
Sponsor's protocol ID
NRG-BN005
Other IDs
NCI-2017-00203, NRG-BN005, NRG-BN005, NRG-BN005, U10CA180868
Status last verified
Jul 2026
First submitted
5 Jun 2017
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma, run by NRG Oncology at 34 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 25 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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.

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?

This study is still under way. Results are not available in the source record yet.

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 cognition as measured by the Clinical Trial Battery Composite (CTB COMP) score (time frame: Baseline to up to 10 years). 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 NCT03180502.

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 28 Jul 2026.

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