Mild Cognitive Impairment (MCI)Phase 1SONATASNCT07210528
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study
A Phase 1 study testing Emtricitabine (FTC) and Descovy® (TAF/FTC) in people with Mild Cognitive Impairment (MCI) and Alzheimer Dementia (AD), run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Alzheimer Dementia (AD)
- What is being tested?
- Emtricitabine (FTC) and Descovy® (TAF/FTC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Jun 2025to Sep 2026
- Phase
- Phase 1
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CDR-GS of 0 or 0.5 (calculated by the QDRS)
- Diagnosed with MCI, determined by impairment in at least one domain of the neuropsychological test battery without significant dysfunction in activities of daily living OR MCI consistent with the NIA/AA diagnostic criteria; OR presenting with SCD and a CDR-GS of 0.5.
- Does not have any medical condition (e.g. cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.
- Willingness to provide blood sample and neuropsychological testing for the study.
- Ability for the patient to provide informed consent.
Who cannot join
- Patient who is receiving a prescription of acetylcholinesterase inhibitor (AChEI) and/or Memantine at screening or baseline.
- Patients with a history of HIV or HBV infection, or that test positive for HIV or HBV on screening.
- Pre-existing comorbidities such as Hepatits, cardiovascular disease, or renal insufficiency.
- History of Moderate to severe hepatic impairment indicated by screening AST or ALT > 3x the upper limit of normal (ULN) or total bilirubin > 2x ULN.
- Patients with severe renal impairment, or creatinine clearance ≤ 30 mL/min (calculated by Cockcroft-Gault formulae at screening).
- Co administration of nephrotoxic drugs.
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- Current or previous RTi use within the last 2 years.
- Malignant neoplasm, and are undergoing active treatment.
- Participating in other interventional clinical trials during the course of the study.
- Documented history of lactic acidosis and severe hepatomegaly with steatosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Emtricitabine and Descovy in Patients With Mild Cognitive Impairment.
Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD.
This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets.
Read more
This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention.
This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers.
Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period.
The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.
- Being tested
- Emtricitabine (FTC), Descovy® (TAF/FTC), Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg., Placebo Capsules to Match Emtricitabine Capsules, 200mg.
- Keywords
- Reverse Transcriptase Inhibitors, Mild Cognitive Impairment (MCI), Descovy, Emtricitabine, Alzheimer's Disease (AD)
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine (FTC)Drug
Also called Emtriva
Capsule, 200mg FTC. White Opaque Body / Light Blue Opaque Cap with "GILEAD" and Gilead logo on body. "200 mg" on cap printed in black.
Descovy® (TAF/FTC)Drug
Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg. Tablets, Rectangular-Shaped, Debossed, Film-coated blue.
Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg.Drug
Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25mg. Tablets, Rectangular-Shaped, Debossed, Film-Coated Blue.
Placebo Capsules to Match Emtricitabine Capsules, 200mg.Drug
White Opaque Body/Light Blue Opaque Cap with "GILEAD" and Gilead logo on body, "200 mg" on cap printed in black.
| Study group | Role | What they receive |
|---|---|---|
| Descovy | Experimental | Equal numbers of male and female participants will be recruited in all arms. Descovy, Tablet, 200/25 mg, ct, Bottle, Britestock. Receives: Drug: Descovy® (TAF/FTC) |
| Placebo to Match Descovy | Placebo comparator | Equal numbers of male and female participants will be recruited in all arms. Placebo to match Descovy. Tablets, Rectangular-Shaped, Debossed, Film-Coated Blue, 30ct per bottle. Receives: Drug: Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg. |
| Emtricitabine (Emtriva) | Experimental | Equal numbers of male and female participants will be recruited in all arms. Emtriva, Capsule, 200 mg, 30 ct, Bottle, Britestock. Receives: Drug: Emtricitabine (FTC) |
| Placebo to match Emtricitabine (Emtriva) | Placebo comparator | Equal numbers of male and female participants will be recruited in all arms. Placebo Capsules to Match Emtricitabine Capsules, 200 mg, White Opaque Body/Light Blue Opaque Cap with "GILEAD" and Gilead Logo on body, "200 mg" on cap printed in black, 30 ct per bottle. Receives: Drug: Placebo Capsules to Match Emtricitabine Capsules, 200mg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related Adverse/Serious Adverse Events (AE/SAE)
Number of participants with treatment-related AE/SAEs as assessed on the CTCAE Version 4.0. Incidence rate (n = x, and %), cause, and type of AE/SAE will be compared across the active drug and placebo groups.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Secondary outcomes (10)
Change in circulating Beta-Amyloid 40 (Aβ40), Beta-Amyloid 42 (Aβ42) and Aβ-40: Aβ-42 ratio from baseline.
Changes in plasma Aβ-40 and Aβ-42 levels; and Aβ40:Aβ42 ratio from baseline visit to week 12 visit, as assessed on Single Molecular Array (SIMOA). Units: pg/mL. No reference range is reported as significant variation exists across cohorts.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Phospho-Tau217 (Ptau217) from baseline.
Change in total plasma Ptau217 levels from baseline visit to week 12 visit, as assessed on Single Molecular Array (SIMOA). Units: pg/mL. No reference range is reported as significant variation exists across cohorts.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Interleukin-6 (IL-6) levels from baseline.
Change in serum IL-6 levels from baseline to week 12 visit, as assessed on Luminex Multiplex Analyser. Units: pg/mL. No reference range is reported as significant variation exists across cohorts.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Interleukin-8 (IL-8) levels from baseline.
Change in serum IL-8 levels from baseline to week 12 visit, as assessed on Luminex Multiplex Analyser. Units: pg/mL. No reference range is reported as significant variation exists across cohorts.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Tumor Necrosis Factor-alpha (TNFα) levels from baseline.
Change in serum TNFα levels from baseline to week 12 visit, as assessed on Luminex Multiplex Analyser. Units: pg/mL. No reference range is reported as significant variation exists across cohorts.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Mini Mental State Exam scores (MMSE).
Change in MMSE total scores from baseline visit to week 12 visit, to assess changes in cognitive function. Scores range from 0 - 30, with higher scores indicating better cognitive function.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Quick Dementia Rating Scores (QDRS) from baseline.
Change in QDRS total scores from baseline visit to week 12 visit, to assess changes in cognitive function. Scores range from 0 - 30, with higher scores indicating greater cognitive and functional impairment.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from baseline.
Change in RBANS total and index scores from baseline to week 12 visit to assess changes in cognitive function. The battery consists of 5 indexes: 1) Immediate Memory, 2) Visuospatial/Constructional, 3) Language, 4) Attention, and 5) Delayed Memory and 12 subtests which are indexed and scored according to standardized RBANS criteria - adjusting for age and education):
Immediate Memory: List Learning, Story Memory; Visuospatial/Constructional: Figure Copy, Line Orientation; Language: Picture Naming, Semantic Fluency; Attention: Digit Span, Coding; Delayed Memory: List Recall, List Recognition, Story Recall, Figure Recall.
Raw scores of all 12 subtests will be converted to age- and education-adjusted scaled scores before calculating an index score for each domain. Sum of index scores will then be converted to a Total Scale score. Scaled scores range from 40 - 160, with higher scores indicating higher overall cognitive function.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Colour Trials Test (CTT) scores from baseline.
Change in CTT (Trial 1 \& 2) completion times from baseline to week 12 visit, to assess changes in attention and sequencing. Units: Time-to-completion (seconds) for each Trial. A range of time-to-completion of 3-8 minutes is reported in the CTT manual, with longer completion times indicative of impaired attention and sequencing.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Activities of Daily Living (ADL) scores from baseline.
Change in Independent ADL scores from baseline to week 12 visit, as assessed on the Activities of Daily Living Preventative Instrument (ADCS-ADL-PI) - comprising 15 ADL and 5 physical function questions covering complex activities typically conducted by most during independent living (e.g. handling money, shopping, remembering plans and appointments).
ADLs are scored on a 5-point Likert scale. Total scores range from 0 - 45, with higher scores indicating less functional impairment.
Measured: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start30 Jun 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Chen, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210528
- Sponsor's protocol ID
- RTi-EmtriDes-2022
- Acronym
- SONATAS
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive health information will be collected as part of this study. Only de-indentified data will be used for study purposes.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Emtricitabine and Descovy in Patients With Mild Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT07210528
- Acronym / sponsor ID
- SONATAS / RTi-EmtriDes-2022
- Keywords
- Reverse Transcriptase Inhibitors, Mild Cognitive Impairment (MCI), Descovy, Emtricitabine, Alzheimer's Disease (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Oct 2025 (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.
Recent studies have identified an association between Alzheimer's Disease (AD) and an expansion of DNA content in the brain (prefrontal cortex). This additional DNA content appears to be derived from reverse transcriptase (RT) activity that incorporates genomic cDNAs (gencDNAs) into chromosomes, resulting in multiple copies of full length and shorter cDNAs involving many genes - including the causal AD gene amyloid precursor protein (APP). Accumulation of these APP gencDNAs is associated with AD.
This identifies RT as a promising therapeutic target for the attenuation of AD progression through existing reverse transcriptase inhibitors (RTi's) that have been widely used for treating HIV and hepatitis B. Since this class of drugs has been in the clinic for over 3 decades, there are significant data supporting their post-approval safety for long-term use. However, this has not been specifically addressed in the target population - patients with mild cognitive impairment (MCI), particularly women - who are underrepresented in HIV datasets.
This proposed Phase I safety trial will perform a Special Population Study in a cohort of MCI patients who may benefit from the intervention.
This study aims to (1) evaluate the safety and tolerability of standard dose FTC or Descovy for 3 months in MCI patients; (2) as secondary aims, collect preliminary data on clinical effects of standard dose FTC or Descovy compared to placebo for 3 months on cogntiive function in MCI patients; and (3) collect preliminary data on clinical effects of standard dose FTC or Descovy compared with placebo on AD-associated inflammatory markers.
Participants will be randomized into either Descovy or FTC arms in equal numbers, and receive either active drug or placebo. Participants will orally ingest 1 capsule or tablet (depending on drug arm) daily for the 3 month participation period.
The investigators hypothesise that MCI are not at increased risk of adverse effects due to administration of standard dose FTC or Descovy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Descovy | Experimental | Drug: Descovy® (TAF/FTC)Equal numbers of male and female participants will be recruited in all arms. Descovy, Tablet, 200/25 mg, ct, Bottle, Britestock. |
| Placebo to Match Descovy | Placebo comparator | Drug: Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg.Equal numbers of male and female participants will be recruited in all arms. Placebo to match Descovy. Tablets, Rectangular-Shaped, Debossed, Film-Coated Blue, 30ct per bottle. |
| Emtricitabine (Emtriva) | Experimental | Drug: Emtricitabine (FTC)Equal numbers of male and female participants will be recruited in all arms. Emtriva, Capsule, 200 mg, 30 ct, Bottle, Britestock. |
| Placebo to match Emtricitabine (Emtriva) | Placebo comparator | Drug: Placebo Capsules to Match Emtricitabine Capsules, 200mg.Equal numbers of male and female participants will be recruited in all arms. Placebo Capsules to Match Emtricitabine Capsules, 200 mg, White Opaque Body/Light Blue Opaque Cap with "GILEAD" and Gilead Logo on body, "200 mg" on cap printed in black, 30 ct per bottle. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CDR-GS of 0 or 0.5 (calculated by the QDRS)
- Diagnosed with MCI, determined by impairment in at least one domain of the neuropsychological test battery without significant dysfunction in activities of daily living OR MCI consistent with the NIA/AA diagnostic criteria; OR presenting with SCD and a CDR-GS of 0.5.
- Does not have any medical condition (e.g. cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments.
- Willingness to provide blood sample and neuropsychological testing for the study.
- Ability for the patient to provide informed consent.
Key exclusion criteria (10 listed)
- Patient who is receiving a prescription of acetylcholinesterase inhibitor (AChEI) and/or Memantine at screening or baseline.
- Patients with a history of HIV or HBV infection, or that test positive for HIV or HBV on screening.
- Pre-existing comorbidities such as Hepatits, cardiovascular disease, or renal insufficiency.
- History of Moderate to severe hepatic impairment indicated by screening AST or ALT > 3x the upper limit of normal (ULN) or total bilirubin > 2x ULN.
- Patients with severe renal impairment, or creatinine clearance ≤ 30 mL/min (calculated by Cockcroft-Gault formulae at screening).
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 |
|---|---|---|
| Emtricitabine (FTC)Also: EmtrivaCapsule, 200mg FTC. White Opaque Body / Light Blue Opaque Cap with "GILEAD" and Gilead logo on body. "200 mg" on cap printed in black. | Drug | Emtricitabine (Emtriva) |
| Descovy® (TAF/FTC)Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg. Tablets, Rectangular-Shaped, Debossed, Film-coated blue. | Drug | Descovy |
| Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg.Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25mg. Tablets, Rectangular-Shaped, Debossed, Film-Coated Blue. | Drug | Placebo to Match Descovy |
| Placebo Capsules to Match Emtricitabine Capsules, 200mg.White Opaque Body/Light Blue Opaque Cap with "GILEAD" and Gilead logo on body, "200 mg" on cap printed in black. | Drug | Placebo to match Emtricitabine (Emtriva) |
Primary outcome
Number of participants with treatment-related Adverse/Serious Adverse Events (AE/SAE)
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Number of participants with treatment-related AE/SAEs as assessed on the CTCAE Version 4.0. Incidence rate (n = x, and %), cause, and type of AE/SAE will be compared across the active drug and placebo groups.
10 secondary outcomes
Change in circulating Beta-Amyloid 40 (Aβ40), Beta-Amyloid 42 (Aβ42) and Aβ-40: Aβ-42 ratio from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Phospho-Tau217 (Ptau217) from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Interleukin-6 (IL-6) levels from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Interleukin-8 (IL-8) levels from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Tumor Necrosis Factor-alpha (TNFα) levels from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Mini Mental State Exam scores (MMSE).
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Quick Dementia Rating Scores (QDRS) from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Colour Trials Test (CTT) scores from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Change in Activities of Daily Living (ADL) scores from baseline.
Time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Sensitive health information will be collected as part of this study. Only de-indentified data will be used for study purposes.
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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.
Christopher Chen principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emtricitabine (FTC) and Descovy® (TAF/FTC) in people with Mild Cognitive Impairment (MCI) and Alzheimer Dementia (AD), run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. 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 Singapore. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with treatment-related Adverse/Serious Adverse Events (AE/SAE) (time frame: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.