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Alzheimer Dementia (AD) / Emtricitabine (FTC) / Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg. · Phase 1 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 safety trial registration (not yet reporting results) evaluating reverse transcriptase inhibitors (emtricitabine and TAF/FTC) in patients with mild cognitive impairment, based on a hypothesis that reverse transcriptase activity contributes to Alzheimer's disease. The trial is active but not yet recruiting, with 48 planned participants and a 12-week treatment period; primary outcome is safety and tolerability, with secondary collection of preliminary cognitive and inflammatory biomarker data.
Phase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Mild Cognitive Impairment (MCI), Alzheimer Dementia (AD); age from 50 Years; to 85 Years. Intervention: Descovy; Emtricitabine (Emtriva). Compared with: Placebo to Match Descovy — Placebo Comparator; Placebo to match Emtricitabine (Emtriva) — Placebo Comparator. n = 48. 1 site: Singapore.
This is a Phase 1 safety trial registration (not yet reporting results) evaluating reverse transcriptase inhibitors (emtricitabine and TAF/FTC) in patients with mild cognitive impairment, based on a hypothesis that reverse transcriptase activity contributes to Alzheimer's disease. The trial is active but not yet recruiting, with 48 planned participants and a 12-week treatment period; primary outcome is safety and tolerability, with secondary collection of preliminary cognitive and inflammatory biomarker data.
Study is Phase 1 focused on safety; no efficacy or effect size data will be available from this trial design.
No clinical impact can be assessed at this stage, as no results have been reported. This trial is designed as a first step to establish safety tolerability of reverse transcriptase inhibitors in MCI patients before any efficacy work.
Phase 1 safety trial in a special population (MCI patients) with no results yet reported; designed to evaluate tolerability and collect preliminary cognitive and biomarker data over 12 weeks.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed at this stage, as no results have been reported. This trial is designed as a first step to establish safety tolerability of reverse transcriptase inhibitors in MCI patients before any efficacy work.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07210528). This is a study registration, not published results. Lead sponsor: National University Hospital, Singapore. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 48 participants (ESTIMATED). Conditions: Mild Cognitive Impairment (MCI), Alzheimer Dementia (AD). Interventions: DRUG: Emtricitabine (FTC); DRUG: Descovy® (TAF/FTC); DRUG: Placebo to Match Emtricitabine 200mg/Tenofovir Alafenamide 25 mg.; DRUG: Placebo Capsules to Match Emtricitabine Capsules, 200mg.. Primary outcome measures: Number of participants with treatment-related Adverse/Serious Adverse Events (AE/SAE) , From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).. Brief 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 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.