Conditions: Stroke
Keywords: Stroke Vascular cognitive impairment Coiling Endovascular repair Brain aneurysm NA-1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 185
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage. Up to 200 male and female patients undergoing endovascular repair of brain aneurysm will be dosed with 2.60 mg/kg of NA-1 or placebo as a 10 minute intravenous infusion after completion of the endovascular procedure on Day 1 of the study period. Subjects will undergo interim procedures Days 2-4 and end-of study procedures on Day 30. Standard safety criteria will be analysed. Efficacy endpoints include the ability of NA-1 to: 1) reduce the volume of ischemic embolic strokes, 2) reduce the number of ischemic embolic strokes, 3) reduce vascular cognitive impairment, and 4) reduce the frequency of large strokes induced by the endovascular procedure. The plasma concentrations of NA-1 will also be analyzed.

Detailed description:

Arms:
arm 1: 20 amino acid peptide that consists of a 9 amino acid domain that inhibits PSD-95 and a 11 amino acid domain than enables the peptide to cross the blood-brain barrier. arm 2: None

Interventions: intervention 1: NA-1 intervention 2: Placebo
Intervention descriptions: intervention 1: single intravenous dose of 2.6 mg/kg of NA-1 administered as a 10-minute infusion intervention 2: single intravenous dose of 2.6 mg/kg of placebo administered as a 10-minute infusion

Protocol document: