Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study (NCT07210528) | Clinical Trial Compass
RecruitingPhase 1
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study
Singapore48 participantsStarted 2025-06-30
Plain-language 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.
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily focused on safety, what do we actually know so far about whether NRTIs help with Alzheimer's or MCI — and would joining this study mean I might not be getting a treatment proven to slow my condition?
2The trial is measuring treatment-related adverse and serious adverse events — what kinds of side effects are known or suspected with NRTIs in older adults, and are there any risks that might be especially relevant given my current health situation?
3NRTIs are a class of drugs originally developed for HIV — can you explain why researchers think these medications might be worth testing for Alzheimer's or mild cognitive impairment, and does that reasoning make sense for someone at my stage?
4Because this is an early-phase safety study recruiting now in Singapore, what would my commitment look like in terms of visits, monitoring, and follow-up, and is that realistic for my day-to-day life?
5Before we consider this trial, is there a standard treatment path for mild cognitive impairment or early Alzheimer's that you'd recommend I try first, and how does participating in a Phase 1 study fit into that overall plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related Adverse/Serious Adverse Events (AE/SAE)
Timeframe: From enrollment to the end of treatment at 12 weeks (measured from participant's baseline visit).