HivEarly Phase 1MsSCORENCT03237689
Effects of Glucocorticoids on Cognition in HIV-infected Women
A Early Phase 1 study testing Hydrocortisone in people with Hiv, run by Johns Hopkins University at 1 site in United States.
Trial summary
Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hiv
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 8 Sep 2023
- Phase
- Early Phase 1
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females only;
- HIV-infected;
- Able to give informed consent;
- Able to travel to study site for study participation;
- Age between 18 and 65;
- English as a first language;
Show all 9Show fewer
- Above-average self-reported levels of perceived stress (>14 on the perceived stress scale (PSS-10)) and/or current SCID-V diagnosis of mood and/or anxiety disorder;
- Meet criteria for HIV-associated cognitive dysfunction (based on Neurocognitive test battery and instrumental activities of daily living assessment-impairment on only 1 cognitive domain is required)
- Virally suppressed and on combination antiretroviral therapy (Plasma HIV RNA<1000cp/ml and bring in medications)
Who cannot join
- Current use of hormone-based contraceptives (birth control pills or patch);
- Currently pregnant, post-partum or lactating;
- Currently regular use of steroids;
- History of closed head injury resulting in loss of consciousness greater than 1 hour;
- History of schizophrenia or schizoaffective disorder;
- Current untreated hypertension or diabetes*;
Show all 10Show fewer
- History of dementia or any other neurologic central nervous system (CNS) or AIDS-defining disorder;
- Positive urine toxicology screen (except marijuana) or breathalyzer and/or any evidence of acute intoxication or withdrawal.
- History of substance abuse/dependence in the past six months.
- Participants who present with a heretofore untreated condition (e.g., hypertension) will be excluded; however, they may be rescreened for eligibility after receiving appropriate treatment for the condition in the course of their standard medical care (at least 6 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.
Read the detailed description
The overall aim of this study is to contribute important foundational knowledge of the utility of targeting neuroinflammation and the hypothalamic-pituitary-adrenal (HPA) axis to improve cognition in HIV and will provide key clinical insights into the mechanisms underlying any cognitive benefit. The investigators are conducting a single-dose study of low dose hydrocortisone (LDH) followed by a 4-week study of daily LDH as a probe of the mechanisms of neuroinflammation including myeloid-lineage cells and the HPA axis in HIV-infected (HIV+) women demonstrating cognitive dysfunction and reporting high levels of stress, trauma history, and mental health risk factors which commonly occur in this population. The use of a pharmacological challenge may aid in the identification of: 1) a putative biomarker of stress- and psychiatric disorder-related neurocognitive complications in HIV-infected women and/or 2) an adjunctive, cost-effective therapy for the treatment of cognitive deficits in HIV
The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind, placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind, placebo controlled trial of daily LDH for 4 weeks on cognition and side effects. The clinical trial will include 100 virally suppressed HIV+ women who show elevated stress and cognitive impairment and who represent the range of psychological risk factors characteristic of this population. Next, to understand the mechanism and broader clinical significance of LDH on cognition, investigators will conduct a 4-week randomized study of the effects of daily treatment with LDH versus placebo on cognition in HIV+ women (targeted n=80).
Women meeting enrollment criteria will complete three cognitive assessments. The first and second assessments will be embedded in the double-blind, placebo-controlled, cross-over study of a single administration of LDH versus placebo (targeted n=100). Investigators will measure cognitive performance 30 minutes and 4 hours post-dosing, because an emerging literature shows that the cognitive effects of LDH depends on timing of the assessment post-dosing. The 30-minute assessment addresses how the maximal cortisol levels following LDH affect cognition. This immediate assessment is standard in studies of stress and cognition and allows for comparisons with the broader literature. More novel and clinically important is the 4-hour assessment which occurs post-peak, when cortisol levels are more steady state and typical of the broader daily cortisol profile following LDH. The third assessment will take place after 4 weeks of treatment with LDH or placebo. That assessment addresses the clinical significance and safety of longer-term LDH treatment. Lastly, the investigators will explore glucocorticoids and inflammation and immune activation as mechanisms by which LDH might affect cognition.
Objective 1 To examine immediate and delayed effects of a single administration of LDH on cognition in HIV+ women.
Objective 2 To examine the effects of a 4-week course of daily LDH on cognition in HIV+ women.
Objective 3 To investigate potential mechanisms of LDH effects on cognition in HIV+ women.
- Conditions
- Hiv
- Being tested
- Hydrocortisone, Placebo Oral Tablet
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Low dose hydrocortisone (10mg)
Placebo Oral TabletDrug
capsules of starch 1500 powder
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | Low dose hydrocortisone (10mg orally) Receives: Drug: Hydrocortisone |
| Placebo | Placebo comparator | Placebo tablets, made of starch 1500 powder Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning Test-Revised assesses total learning
a 12-item list-learning task across 3 trials used to measure total learning. Outcome=total learning across trials (range 0-36). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Hopkins Verbal Learning Test-Revised assesses verbal memory
following the 3 learning trials there is a 20-25 minute delay. After the delay, participants are asked to recall as many words as they can from the initial learning list. Outcome=delayed free recall (range 0-12).Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Wechsler Adult Intelligence Scale IV Letter-Number Sequencing assesses working memory condition
participants hear a series of letters and numbers, and then recite them back in ascending order, with the numbers first and then the letters. Outcome=total correct (range 0-24). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Line Orientation Task assesses visuospatial abilities
In each of 10 trials, a visual array of 13 lines fans out from a common point of origin. Two target lines are shown beneath each array, and participants must identify the lines within the array that match each of the two target lines. Outcome=Total correct (range=0-20).
Measured: change between baseline and 28 days
Secondary outcomes (11)
Trail Making Test Part A assesses processing speed/attention
25 circles distributed over a sheet of paper. The circles are numbered 1 - 25 and the participant should draw lines to connect the numbers in ascending order. Outcome=Time to completion (range: 10 to 300 seconds). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Trail Making Test Part B assesses mental flexibility
25 circles are distributed over a sheet of paper. Circles include both numbers (1 - 13) and letters (A - L). The participant draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Outcome=time to completion (range: 18-300). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Comalli Stroop Test, Trial 1 assesses processing speed/attention
Participants identify aloud the colors of a series of squares. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Comalli Stroop Test, Trial 2 assesses processing speed/attention
Participants read a series of color names printed in black ink. Outcome=time to completion (range: 30 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Comalli Stroop Test, Trial 3 assesses behavioral inhibition
Participants name the color of the ink but ignore the word. Outcome=time to completion (range: 50 to 240). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Measured: change between baseline and 28 days
Liver function as assessed by aspartate aminotransferase (AST) levels
levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
Measured: change between baseline and 28 days
Liver function as assessed by alanine transaminase (ALT) levels
levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
Measured: change between baseline and 28 days
Liver function as assessed by alkaline phosphatase levels
levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
Measured: change between baseline and 28 days
renal function assessed by creatinine levels
levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
Measured: change between baseline and 28 days
metabolic function assessed by glucose levels
levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
Measured: change between baseline and 28 days
metabolic function assessed by hemoglobin A1c (HbA1c)
levels from blood. Clinical significance will be determined using the Division of AIDS (DAIDS) Table for grading the severity of adult and pediatric adverse events.
Measured: change between baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start20 Nov 2017
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind, placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind, placebo controlled trial of daily LDH for 4 weeks on cognition and side effects. Below includes the number of arms for the second study phase and is the phase of the study being considered a Phase 0 clinical trial. All information to follow will pertain to this phase of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Leah Rubin, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237689
- Sponsor's protocol ID
- IRB00145327
- Other IDs
- R01MH113512
- Acronym
- MsSCORE
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rubin LH, Xu Y, Wu S, Coughlin JM, Brown TT, Dastgheyb RM, Pohlenz L, Shirk E, Romero H, Veenhuis RT, Premeaux TA, Ndhlovu LC, Howell PA, Stadtler H, Neigh GN, Maki PM. Low-Dose Hydrocortisone and Cognition in Women With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2629185. doi: 10.1001/jamanetworkopen.2026.29185.
PubMed 42606862
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucocorticoids on Cognition in HIV-infected Women
- ClinicalTrials.gov ID
- NCT03237689
- Acronym / sponsor ID
- MsSCORE / IRB00145327
- Conditions
- Hiv
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 2 Aug 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.
Despite treatment with antiretroviral therapy, women living with HIV continue to experience cognitive impairment. Psychological risk factors, including stress, impair cognition more in HIV-infected women than HIV-uninfected women. This study plans to examine a novel intervention for cognitive dysfunction that targets the mechanisms by which stress negatively affects cognitive functioning.
Detailed description
The overall aim of this study is to contribute important foundational knowledge of the utility of targeting neuroinflammation and the hypothalamic-pituitary-adrenal (HPA) axis to improve cognition in HIV and will provide key clinical insights into the mechanisms underlying any cognitive benefit. The investigators are conducting a single-dose study of low dose hydrocortisone (LDH) followed by a 4-week study of daily LDH as a probe of the mechanisms of neuroinflammation including myeloid-lineage cells and the HPA axis in HIV-infected (HIV+) women demonstrating cognitive dysfunction and reporting high levels of stress, trauma history, and mental health risk factors which commonly occur in this population. The use of a pharmacological challenge may aid in the identification of: 1) a putative biomarker of stress- and psychiatric disorder-related neurocognitive complications in HIV-infected women and/or 2) an adjunctive, cost-effective therapy for the treatment of cognitive deficits in HIV
The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind, placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind, placebo controlled trial of daily LDH for 4 weeks on cognition and side effects. The clinical trial will include 100 virally suppressed HIV+ women who show elevated stress and cognitive impairment and who represent the range of psychological risk factors characteristic of this population. Next, to understand the mechanism and broader clinical significance of LDH on cognition, investigators will conduct a 4-week randomized study of the effects of daily treatment with LDH versus placebo on cognition in HIV+ women (targeted n=80).
Women meeting enrollment criteria will complete three cognitive assessments. The first and second assessments will be embedded in the double-blind, placebo-controlled, cross-over study of a single administration of LDH versus placebo (targeted n=100). Investigators will measure cognitive performance 30 minutes and 4 hours post-dosing, because an emerging literature shows that the cognitive effects of LDH depends on timing of the assessment post-dosing. The 30-minute assessment addresses how the maximal cortisol levels following LDH affect cognition. This immediate assessment is standard in studies of stress and cognition and allows for comparisons with the broader literature. More novel and clinically important is the 4-hour assessment which occurs post-peak, when cortisol levels are more steady state and typical of the broader daily cortisol profile following LDH. The third assessment will take place after 4 weeks of treatment with LDH or placebo. That assessment addresses the clinical significance and safety of longer-term LDH treatment. Lastly, the investigators will explore glucocorticoids and inflammation and immune activation as mechanisms by which LDH might affect cognition.
Objective 1 To examine immediate and delayed effects of a single administration of LDH on cognition in HIV+ women.
Objective 2 To examine the effects of a 4-week course of daily LDH on cognition in HIV+ women.
Objective 3 To investigate potential mechanisms of LDH effects on cognition in HIV+ women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a two-phase study of HIV+ women who: 1) first participate in a double-blind, placebo-controlled cross-over study of a single, low dose (10 mg) of hydrocortisone versus placebo on cognition; and 2) then participate in a mechanistic, randomized, double-blind, placebo controlled trial of daily LDH for 4 weeks on cognition and side effects. Below includes the number of arms for the second study phase and is the phase of the study being considered a Phase 0 clinical trial. All information to follow will pertain to this phase of the study.
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Drug: HydrocortisoneLow dose hydrocortisone (10mg orally) |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo tablets, made of starch 1500 powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females only;
- HIV-infected;
- Able to give informed consent;
- Able to travel to study site for study participation;
- Age between 18 and 65;
Key exclusion criteria (10 listed)
- Current use of hormone-based contraceptives (birth control pills or patch);
- Currently pregnant, post-partum or lactating;
- Currently regular use of steroids;
- History of closed head injury resulting in loss of consciousness greater than 1 hour;
- History of schizophrenia or schizoaffective disorder;
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 |
|---|---|---|
| HydrocortisoneLow dose hydrocortisone (10mg) | Drug | Hydrocortisone |
| Placebo Oral Tabletcapsules of starch 1500 powder | Drug | Placebo |
Primary outcome
Hopkins Verbal Learning Test-Revised assesses total learning
Time frame: change between baseline and 28 days
a 12-item list-learning task across 3 trials used to measure total learning. Outcome=total learning across trials (range 0-36). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Hopkins Verbal Learning Test-Revised assesses verbal memory
Time frame: change between baseline and 28 days
following the 3 learning trials there is a 20-25 minute delay. After the delay, participants are asked to recall as many words as they can from the initial learning list. Outcome=delayed free recall (range 0-12).Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Wechsler Adult Intelligence Scale IV Letter-Number Sequencing assesses working memory condition
Time frame: change between baseline and 28 days
participants hear a series of letters and numbers, and then recite them back in ascending order, with the numbers first and then the letters. Outcome=total correct (range 0-24). Neuropsychological measures are normed on populations and therefore the clinical significance of a score can be assessed in relation to expected levels of performance.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Line Orientation Task assesses visuospatial abilities
Time frame: change between baseline and 28 days
In each of 10 trials, a visual array of 13 lines fans out from a common point of origin. Two target lines are shown beneath each array, and participants must identify the lines within the array that match each of the two target lines. Outcome=Total correct (range=0-20).
11 secondary outcomes
Trail Making Test Part A assesses processing speed/attention
Time frame: change between baseline and 28 days
Trail Making Test Part B assesses mental flexibility
Time frame: change between baseline and 28 days
Comalli Stroop Test, Trial 1 assesses processing speed/attention
Time frame: change between baseline and 28 days
Comalli Stroop Test, Trial 2 assesses processing speed/attention
Time frame: change between baseline and 28 days
Comalli Stroop Test, Trial 3 assesses behavioral inhibition
Time frame: change between baseline and 28 days
Liver function as assessed by aspartate aminotransferase (AST) levels
Time frame: change between baseline and 28 days
Liver function as assessed by alanine transaminase (ALT) levels
Time frame: change between baseline and 28 days
Liver function as assessed by alkaline phosphatase levels
Time frame: change between baseline and 28 days
renal function assessed by creatinine levels
Time frame: change between baseline and 28 days
metabolic function assessed by glucose levels
Time frame: change between baseline and 28 days
metabolic function assessed by hemoglobin A1c (HbA1c)
Time frame: change between baseline and 28 days
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 Sep 2023.
- Derived from this study: PubMed 42606862Rubin LH, Xu Y, Wu S, Coughlin JM, Brown TT, Dastgheyb RM, Pohlenz L, Shirk E, Romero H, Veenhuis RT, Premeaux TA, Ndhlovu LC, Howell PA, Stadtler H, Neigh GN, Maki PM. Low-Dose Hydrocortisone and Cognition in Women With HIV: A Randomized Clinical Trial. JAMA Netw Open. 2026 Aug 3;9(8):e2629185. doi: 10.1001/jamanetworkopen.2026.29185.
- Brief Report: Low-Dose Hydrocortisone Has Acute Enhancing Effects on Verbal Learning in HIV-Infected MenLink provided by the sponsor.
- Elevated stress is associated with prefrontal cortex dysfunction during a verbal memory task in women with HIVLink provided by the sponsor.
- Prefrontal cortical volume loss is associated with stress-related deficits in verbal learning and memory in HIV-infected womenLink provided by the sponsor.
- Post-traumatic stress is associated with verbal learning, memory, and psychomotor speed in HIV-infected and HIV-uninfected womenLink provided by the sponsor.
- The association of perceived stress and verbal memory is greater in HIV-infected versus HIV-uninfected womenLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Leah Rubin principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hydrocortisone in people with Hiv, run by Johns Hopkins University 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 9 inclusion and 10 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 Sep 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Verbal Learning Test-Revised assesses total learning (time frame: change between baseline and 28 days). The study lists 4 primary outcomes in all. 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 NCT03237689, which also lists 1 linked publication.
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 Sep 2023.