drugset / Trial / NCT04966429

Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment

NCT04966429

RandomizedParallel-groupTriple-blindTreatment

Summary

Hypotheses: 1. Subjects with mild post-stroke cognitive impairment (PSCI) are at risk of developing vascular dementia (VaD). Maraviroc treatment in patients suffering from mild PSCI will halt its progression and improve cognitive outcome by affecting synaptic plasticity. 2. CCR5 inhibition produces an anti-inflammatory and anti-atherogenic effect by lowering macrophage infiltration and adhesion molecules. Thus, PSCI patients treated with Maraviroc will present a better inflammatory profile and a deceleration of carotid atherosclerosis, vs. placebo. Objectives: To investigate the safety and efficacy of Maraviroc 150 mg and 600 mg per day vs. placebo in patients with recent subcortical stroke who experience mild PSCI on progression/improvement of clinical symptoms of post-stroke cognitive impairment, change in disease biomarkers and inflammatory profile. The study will include 150 participants aged 50-86 years treated with Maraviroc 150mg or 600mg per day compared to placebo for 12 months in 3 sites.

Timeline

Start
2021-05-01
Primary completion
2024-04
Completion
2024-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Maraviroc Other / unclassified 150 mg
Comparator Maraviroc Other / unclassified 600 mg

Indications