NCT06519357

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Detailed description

To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period. Exploratory objectives To assess the ability of lamivudine to modify retrotransposons expression in cryopreserved PBMCs the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Lamivudine 300 MG	Participants receive 300 mg of Lamivudine daily for 24 weeks

Timeline

• Start date: 2024-10-28
• Primary completion: 2025-09-05
• Completion: 2026-03-01
• First posted: 2024-07-25
• Last updated: 2025-12-04

Locations

1 site across 1 country: Spain