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

NCT ID: NCT00056238

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28

Brief Summary

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

Stroke; Neurologic Diseases, General

Keywords

Neurologic Diseases (General); Hemorrhagic Stroke; Cerebral Amyloid Angiopathy; Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

NC-758 (Anti amyloidotic [Aß] agent)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients must be 55 years of age or older.
• Males and females. Females must be of non-childbearing potential (i.e. surgically sterilized or at least one year post-menopausal).
• Diagnosis of possible or probable CAA based on the Boston Criteria for Diagnosis of CAA-Related Hemorrhage.
• Nonfatal lobar hemorrhage (defined as hemorrhage in the cerebral cortex and underlying white matter sparing the basal ganglia and thalamus) within previous five years diagnosed by CT or MRI scan.
• Patient has no intent to donate blood for 4 weeks after completion of the study.
• Signed informed consent.

Exclusion Criteria

• Other established causes of hemorrhage at the time of the index hemorrhage event. Exclusion causes include excessive anticoagulation (INR > 4.0), associated head trauma or ischemic stroke, CNS tumor, vascular malformation, vasculitis, and blood dyscrasia.
• Patient with a clinically significant and uncontrolled cardiovascular, renal, hepatic, pulmonary, gastrointestinal, endocrine, metabolic, ophthalmologic, hematological condition or other significant medical disease.
• Presence of any condition that could interfere with the interpretation of study results or compromise patient safety.
• Debilitated neurological state or other known disease likely to result in early death.
• Disability characterized by a modified Rankin score ≥ 4.
• ALT, ALP, AST or total bilirubin ≥ 1.5 the upper limit of normal ranges.
• Contraindications to MRI scan (e.g. cranial metallic implant, cardiac pacemaker, and severe claustrophobia).
• Allergy and/or hypersensitivity to analgesic agents used for the lumbar puncture (for patients undergoing lumbar puncture only).
• Allergy and/or hypersensitivity to any component of the study medication.
• Use of an investigational drug within 30 days prior to Screening visit.
• Use of warfarin or warfarin containing compounds and heparin or heparin containing compounds within 7 days prior to Baseline (Week 0) visit.
• Diagnosis of cystatin C amyloid angiopathy.
• Active alcohol and/or drug abuse.
• Inability to provide legal consent

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Bellus Health Inc. - a GSK company

INDUSTRY

Sponsor Role: lead

Principal Investigators

Steven M. Greenberg, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Co-sponsor: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA

Role:

Locations

University of Kentucky

Lexington, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Gervais F, Chalifour R, Garceau D, Kong X, Laurin J, Mclaughlin R, Morissette C, Paquette J. Glycosaminoglycan mimetics: a therapeutic approach to cerebral amyloid angiopathy. Amyloid. 2001 Jul;8 Suppl 1:28-35.

Reference Type: BACKGROUND

PMID: 11676287 (View on PubMed)

M.C. Belanger, P. Krzywkowski, J. Paquette, M. Yu, C. Ramassamy, P. Tremblay, and F. Gervais. Development of Cerebral Amyloid Angiopathy in the TgCRND8 Mouse Model of Alzheimer's Disease. Data presented at the Society for Neuroscience, Orlando, FL, November 2002.

Reference Type: BACKGROUND

Other Identifiers

CL-758003

Identifier Type: -

Identifier Source: org_study_id