Post Stroke Cognitive Impairment Clinical Trial
Official title:
Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment
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.
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: 1. To investigate the safety and tolerability of Maraviroc 150 mg and 600 mg per day vs. placebo in patients with recent subcortical stroke who experience mild PSCI. 2. To evaluate the efficacy of Maraviroc 150 mg and 600 mg/day compared with placebo on progression/improvement of clinical symptoms of post-stroke dementia, as assessed by a change from baseline to Month 12 in composite data derived from dementia assessment cognitive scores. 3. To demonstrate the effect of Maraviroc 150/600 mg vs. placebo on additional outcomes, behavioral, functional, as well as on change in disease biomarkers and inflammatory profile. Design: The study will include recent subcortical stroke patients suffering from PSCI, white matter lesions (WML) and small vessel disease (SVD), who are at risk for progression to dementia. The study will assess change from baseline to Month 12 in safety parameters: adverse drug reactions, incidence of treatment-emergent abnormal laboratory values, vital signs, and electrocardiogram; in cognitive performance, clinical symptoms, and blood, cerebrospinal fluid and neuroimaging measures in 150 participants aged 50-86 years treated with Maraviroc 150mg or 600mg per day compared to placebo for 12 months. The study includes 3 sites in Israel. ;