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Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment

NCT04966429 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-07-19

No results posted yet for this study

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.

Conditions

  • Post Stroke Cognitive Impairment

Interventions

DRUG

Maraviroc

Tablets

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Soroka University Medical Center

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2024-04-30
Completion
2024-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04966429 on ClinicalTrials.gov