Cerebril™ in Patients With Lobar Hemorrhage Related to Cerebral Amyloid Angiopathy

Completed

Phase 2 Results

Trial Description

The main objective of this study is to evaluate the safety, tolerability and pharmacokinetics of Cerebril™ in Cerebral Amyloid Angiopathy (CAA) patients who have had lobar cerebral hemorrhage.

Detailed Description

Hemorrhagic Stroke due to CAA represents approximately 7% of all strokes.
The current phase II clinical study investigates the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of the drug candidate in patients who have suffered lobar hemorrhages. The initial phase of the study is also aimed at determining the optimal dosing regimens for subsequent drug candidate efficacy trials. The trial is also evaluating the appearance of new cerebral hemorrhages on gradient-echo MRI scans, the amyloid ß (Aß) protein levels in the plasma and cerebrospinal fluid and the neurological and cognitive functions.

Conditions

Interventions

  • Cerebril Drug
    Intervention Desc: Cerebril™ is a synthetic small organic molecule that has been specifically designed to modify the course of HS-CAA. By binding with the amyloid (beta) (A(beta)) protein, Cerebril™ is thought to prevent the amyloid fibrils from forming and depositing in the small and intermediate blood vessels of the brain of patients with CAA.
  • NC-758 (Anti amyloidotic [Aß] agent) Drug

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Patient Involvement

Patient were randomized to receive 3 different daily doses of Cerebril and had baseline and follow-up physical exams, lab tests, vital signs, and EKG's. Part of the patients had LP's.

Outcomes

Type Measure Time Frame Safety Issue
No outcomes associated with this trial.

Sponsors