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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post Stroke Cognitive Impairment | Drug: Maraviroc | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment |
Actual Study Start Date : | May 1, 2021 |
Estimated Primary Completion Date : | April 2024 |
Estimated Study Completion Date : | June 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Maraviroc 150 mg per day |
Drug: Maraviroc
Tablets
|
Active Comparator: Maraviroc 600 mg per day |
Drug: Maraviroc
Tablets
|
Placebo Comparator: Placebo |
Drug: Maraviroc
Tablets
|
Ages Eligible for Study: | 50 Years to 86 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Einor Ben assayag, PhD | +972-3-6947868 | einorba@tlvmc.gov.il | |
Contact: Yifat Ashkenazi_danon, BSc | yifatad@tlvmc.gov.il |
Israel | |
Tel Aviv Sourasky Medical Center | Recruiting |
Tel Aviv, Israel | |
Contact: Yifat Ashkenazi-Danon yifatad@tlvmc.gov.il | |
Principal Investigator: Hen Hallevi, MD | |
Sub-Investigator: Einor Ben Assayag, PhD | |
Sub-Investigator: Jeremy Molad, MD | |
Sub-Investigator: Estelle Seyman, MD |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 14, 2021 | ||||||||
First Posted Date ICMJE | July 19, 2021 | ||||||||
Last Update Posted Date | July 19, 2021 | ||||||||
Actual Study Start Date ICMJE | May 1, 2021 | ||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment | ||||||||
Official Title ICMJE | Safety and Efficacy of Maraviroc in Post-stroke Cognitive Impairment | ||||||||
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 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. |
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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 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Post Stroke Cognitive Impairment | ||||||||
Intervention ICMJE | Drug: Maraviroc
Tablets
|
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Study Arms ICMJE |
|
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
150 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2024 | ||||||||
Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 50 Years to 86 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
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Listed Location Countries ICMJE | Israel | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04966429 | ||||||||
Other Study ID Numbers ICMJE | TASMC-21-HH-0625-CTIL | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Tel-Aviv Sourasky Medical Center | ||||||||
Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | Tel-Aviv Sourasky Medical Center | ||||||||
Verification Date | July 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |