A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease This study has been completed.
First Received on July 22, 2009. Last Updated on June 17, 2011 History of Changes Sponsor: Pfizer Information provided by: Pfizer ClinicalTrials.gov Identifier: NCT00945672 Purpose
The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment Official Title: A Phase 2 Double-Blinded, Randomized, Placebo-Controlled, Multicenter Study Evaluating The Safety, Tolerability And Pharmacokinetics/ Pharmacodynamics Of PF-04360365 In Mild To Moderate Alzheimer's Disease Patients
Resource links provided by NLM:
Genetics Home Reference related topics: Alzheimer disease MedlinePlus related topics: Alzheimer's Disease U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
Safety/tolerability/PK of multiple doses of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 1 year (adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) [ Time Frame: 18 months ] [ Designated as safety issue: No ] Brain amyloid burden [ Time Frame: 13 months ] [ Designated as safety issue: No ] CSF abeta [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma abeta, CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; immunogenicity (anti-drug antibodies) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Enrollment: 36 Study Start Date: August 2009 Study Completion Date: June 2011 Primary Completion Date: June 2011 (Final data collection date for primary outcome measure) Arms Assigned Interventions PF-04360365 10 mg/kg: Experimental Intervention: Biological: PF-04360365 10 mg/kg Biological: PF-04360365 10 mg/kg 10 mg/kg every 90 days (5 total doses) PF-04360365 7.5 mg/kg: Experimental Intervention: Biological: PF-04360365 7.5 mg/kg Biological: PF-04360365 7.5 mg/kg 10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses) placebo: Placebo Comparator Intervention: Drug: placebo Drug: placebo placebo administered every 90 days or monthly to match experimental treatment arms.
Eligibility
Ages Eligible for Study: 50 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria
Inclusion Criteria:
Males or females of non childbearing potential, age > or = 50.
Diagnosis of probable Alzheimer's disease, consistent with criteria from both: National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). Diagnostic and Statistical Manual of Mental Disorders (DSM IV). Mini-mental status exam score of 16-26 inclusive. Rosen-Modified Hachinski Ischemia Score of < or = 4.
Exclusion Criteria:
Diagnosis or history of other demential or neurodegenerative disorders. Diagnosis or history of clinically significant cerebrovascular disease. Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities. History of autoimmune disorders. History of allergic or anaphylactic reactions.
Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00945672
Locations Sweden Pfizer Investigational Site Göteborg, Sweden, 413 45 Pfizer Investigational Site Malmo, Sweden, 205 02 Pfizer Investigational Site Molndal, Sweden, 431 41 Pfizer Investigational Site Stockholm, Sweden, 141 86 Sponsors and Collaborators Pfizer Investigators Study Director: Pfizer CT.gov Call Center Pfizer More Information
Additional Information: To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site
No publications provided
Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) ClinicalTrials.gov Identifier: NCT00945672 History of Changes Other Study ID Numbers: A9951007 Study First Received: July 22, 2009 Last Updated: June 17, 2011 Health Authority: Sweden: Medical Products Agency
Keywords provided by Pfizer: Alzheimer's disease amyloid imaging antibody
Additional relevant MeSH terms: Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders
ClinicalTrials.gov processed this record on June 21, 2011