NCT00056238

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 stroke

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2003

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 2003

First QC Date

March 7, 2003

Last Update Submit

June 23, 2005

Conditions

StrokeNeurologic Diseases, General

Keywords

Neurologic Diseases (General)Hemorrhagic StrokeCerebral Amyloid AngiopathyCerebrovascular Accident

Interventions

NC-758 (Anti amyloidotic [Aß] agent)DRUG

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

  • 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.

    PMID: 11676287BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

StrokeNervous System DiseasesHemorrhagic StrokeCerebral Amyloid Angiopathy

Interventions

NC 758Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesAmyloidosisProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Steven M. Greenberg, M.D., PhD.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2003

First Posted

March 10, 2003

Study Start

February 1, 2003

Last Updated

June 24, 2005

Record last verified: 2003-03

Locations

US(5)