Status:
RECRUITING
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Mild Cognitive Impairment (MCI)
Alzheimer Dementia (AD)
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07210528
Start Date
June 30 2025
End Date
April 1 2026
Last Update
October 7 2025
Active Locations (1)
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1
National University Hospital
Singapore, Singapore