Actively Recruiting
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study
Led by National University Hospital, Singapore · Updated on 2025-10-07
48
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MMSE score of 24 or above
- CDR-GS score of 0 or 0.5 as calculated by QDRS
- Diagnosis of mild cognitive impairment (MCI) with impairment in at least one neuropsychological domain but no significant daily living dysfunction, or MCI consistent with NIA/AA criteria
- No unstable or inadequately controlled medical conditions that could affect safety or study assessments
- Willingness to provide blood samples and undergo neuropsychological testing
- Ability to give informed consent
You will not qualify if you...
- Receiving acetylcholinesterase inhibitors (AChEI) or Memantine at screening or baseline
- History of or positive test for HIV or hepatitis B infection
- Pre-existing conditions such as hepatitis, cardiovascular disease, or renal insufficiency
- Moderate to severe liver impairment (AST or ALT > 3x ULN or total bilirubin > 2x ULN)
- Severe kidney impairment or creatinine clearance ≤ 30 mL/min
- Use of nephrotoxic drugs concurrently
- Use of reverse transcriptase inhibitors (RTi) within the last 2 years
- Active malignant cancer under treatment
- Participation in other interventional clinical trials
- History of lactic acidosis and severe liver enlargement with fat accumulation
- History of osteoporosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
J
Jit Hui Mark Lim
CONTACT
V
Veronica Ho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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