Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04966429
Status:
UNKNOWN
Last Update Posted:
2021-07-19
First Post:
2021-07-14
Brief Title:
Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 progressionimprovement 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
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 progressionimprovement 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
Detailed Description:
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 mgday compared with placebo on progressionimprovement 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 150600 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
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 mgday compared with placebo on progressionimprovement 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 150600 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None