SONATAS

RecruitingPhase 1

Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Emtricitabine and Descovy in Patients With Mild Cognitive Impairment.

Lead sponsor

National University Hospital, Singapore

Assets

Descovy® (TAF/FTC) / Emtricitabine

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MMSE 24

Primary endpoint

•Treatment-related Adverse/Serious Adverse Events (AE/SAE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07210528

Org study IDRTi-EmtriDes-2022

Timeline

Milestones

Study start2025-06-30actual

Study first posted2025-10-07actual

Last update posted2025-10-07actual

Primary completion2026-03estimated (month precision)

Study completion2026-04estimated (month precision)

Assets

Drug assets

Descovy® (TAF/FTC)Emtricitabine

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•MMSE score of 24 or above.

•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.

•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

Exclusion criteria

•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.

•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.

•Documented history of osteoporosis.

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Executive function / language

Function / daily living

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

3 endpoints

Secondary/protocol endpoint

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).

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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 from baseline, improvement

Secondary/protocol endpoint

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 from baseline, improvement

Executive function / language

1 endpoint

Secondary/protocol endpoint

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 from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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).

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

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 from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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).

event count, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

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).

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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 from baseline, improvement

Secondary/protocol endpoint/low confidence

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 from baseline, improvement

Secondary/protocol endpoint/low confidence

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 from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.