Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01821118
Other study ID # A9951024
Secondary ID 2013-001557-27
Status Completed
Phase Phase 2
First received March 4, 2013
Last updated May 6, 2016
Start date June 2013
Est. completion date September 2015

Study information

Verified date May 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 55 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients diagnosed with probable CAA using the Boston criteria; with no clinical cognitive impairment

- In general good health

Exclusion Criteria:

- Co-morbid diagnosis of clinically documented Alzheimer's disease or significant cognitive impairment

- Clinically significant syncope, epilepsy, head trauma or clinically significant unexplained loss of consciousness within the last 5 years

- Subject's body weight exceeding 100kg

- Women of childbearing potential.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Ponezumab
Infusion of Ponezumab (Day 1=10mg/kg; Day 30 and Day 60 dose = 7.5mg/kg) or placebo (saline); administered via infusion for a total infusion time of 20 minutes.
Other:
placebo
placebo (saline)- given via infusion total infusion time of 20 minutes

Locations

Country Name City State
Canada University of Calgary/Foothills Medical Centre Calgary Alberta
Canada Sunnybrook Health Sciences Centre Toronto Ontario
France CHRU de Lille Lille Cedex NAP
France CHRU de Lille - Hôpital Roger Salengro Lille Cedex NAP
Netherlands University Medical Center Utrecht Utrecht
United Kingdom University College of London London
United States Boston Medical Center - Menino Pavilion Boston Massachusetts
United States Boston Medical Center - Shapiro Center Boston Massachusetts
United States MGH Stroke Research Center Boston Massachusetts
United States Anthinoula A. Martinos Center for Biomedical Imaging Charlestown Massachusetts
United States UCLA Ronald Reagan Medical Center Los Angeles California
United States Columbia University New York New York
United States Barnes Jewish Hospital St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  France,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline to Day 2 or day 90 in cerebrovascular reactivity. Change from baseline to Day 2 or day 90 in cerebrovascular reactivity as measured by the slope (amplitude over time to peak) from visual task-evoked fMRI. screening +90 days No
Secondary Change from baseline to Day 2 or Day 90 in cerebrovascular reactivity. Change from baseline to Day 2 or Day 90 in cerebrovascular reactivity as measured by the time to peak, magnitude, and time to bseline from visual task-evoked fMRI. screening +90 days No
Secondary Change from baseline of total plasma AB species Change from baseline of total plasma AB species at specified endpoints after the intial dose of study medication on the concentration screening +240 days No
See also
  Status Clinical Trial Phase
Completed NCT05486897 - Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy
Recruiting NCT03969732 - Multimodal Biomarkers for Diagnosis and Prognosis in CAA Phase 3
Completed NCT03542656 - Application of Amyloid PET in Cerebral Amyloid Angiopathy Phase 3
Recruiting NCT04604587 - MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA Phase 3
Completed NCT05565144 - Brain Hemorrhage and Functional Outcome in Stroke Patients With CAA Features on Pre-thrombolysis MRI Treated With Intravenous Thrombolysis (Thrombolysis in CAA) ( Thromb in CAA )
Active, not recruiting NCT03464344 - Cortical Superficial Siderosis and Risk of Recurrent Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy. N/A
Completed NCT03824197 - Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD) N/A
Recruiting NCT06393712 - A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy Phase 2
Active, not recruiting NCT01856699 - Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy N/A
Recruiting NCT06128824 - High Frequency Imaging in Cerebral Amyloid Angiopathy
Not yet recruiting NCT06421532 - Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy Phase 2
Completed NCT05394636 - Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy
Recruiting NCT04204642 - SEarchiNg biomarkErs Cerebral Amyloid Angiopathy (SENECA)
Recruiting NCT05207475 - Safety and Efficacy of Remote Ischemic Conditioning on Cerebral Amyloid Angiopathy. (RIC-CAA) N/A
Recruiting NCT04757597 - Remote Ischemic Conditioning for Cerebral Amyloid Angiopathy-related Intracerebral Hemorrhage N/A
Not yet recruiting NCT02361411 - Methods of Etiological Diagnosis of Cerebral Amyloid Angiopathy N/A
Not yet recruiting NCT04654026 - the Safety and Efficacy of Antiplatelet Therapy in Patients of CAA
Completed NCT05082194 - Balance Eyesight and Muscle Tension in the Cervical Spine in Cerebral Amyloid Angiopathy
Completed NCT04825808 - Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.
Recruiting NCT05680389 - Antibiotics Against Amyloid Angiopathy Phase 1/Phase 2