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Tests treatment safety and results for Mild Cognitive Impairment (MCI)
Official title Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study
ClinicalTrials.gov ID: NCT07210528
What this study is testing
What is Emtricitabine (FTC)?
Emtricitabine (FTC) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for mild cognitive impairment (mci).
Also referred to as Emtriva.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- 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...
- Does not have any medical condition (e.g. cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or...
- Willingness to provide blood sample and neuropsychological testing for the study.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- Willingness to provide blood sample and neuropsychological testing for the study.
- Ability for the patient to provide informed consent.
- 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 treatment clinical trials during the course of the study.
- Documented history of lactic acidosis and severe hepatomegaly with steatosis.
- Documented history of osteoporosis.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.