Active — Not RecruitingPhase 2

A Single-center, Self-controlled, Prospective Case Series Pilot Study to Assess the Effect of Lamivudine (3TC) on Neurocognitive Impairment Biomarkers and Type-I IFN (Interferon)-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment (MCI)

Spain23 participantsStarted 2024-10-28

Plain-language summary

To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period. To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).

Who can participate

Age range55 Years – 90 Years

SexALL

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Exclusion criteria

✕. Severe liver dysfunction (Alanine aminotransferase \> 2x upper limit of normal (ULN), aspartate aminotransferase \> 2x ULN, or history of clinically significant liver disease in the investigator's judgment.
✕. Hemoglobin ≤ 10 g/dl.
✕. International Normalized Ratio (INR) \> 1.5 or total bilirubin \> 1.5 x ULN (unless subject has evidence of Gilbert's disease).
✕. Renal impairment Creatinine clearance (CrCl) \< 45 ml/min.
✕. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) \> 8.
✕. Positive blood screen for Human Immunodeficiency Virus (HIV-1 and 2), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus antibodies (HCV-Ab) at Screening.

What they're measuring

To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.

Timeframe: 24 weeks

To assess the incidence, nature, and severity of Treatment Emergent Adverse Events (TEAE).

Timeframe: 48 weeks

Trial details

NCT IDNCT06519357

SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-05

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