This ph 2 study ends AUG 2011
Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
This study is ongoing, but not recruiting participants.
First Received on July 23, 2008. Last Updated on June 2, 2011 History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00722046
Purpose
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.
Condition Intervention Phase
Alzheimer's Disease
Biological: PF-04360365 0.1 mg/kg
Biological: PF-04360365 0.5 mg/kg
Biological: PF-04360365 1 mg/kg
Drug: Placebo
Biological: PF-04360365 3 mg/kg
Biological: PF-04360365 8.5 mg/kg
Phase II
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 Multicenter, Randomized, Double Blind, Placebo-Controlled Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease
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 of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 18 months. (adverse events, physical/neurologic exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Pharmacokinetics of PF-04360365 following administration of multiple doses in subjects with mild to moderate Alzheimer's disease. (plasma and cerebrospinal fluid (as available) PF-04360365 concentrations) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma/CSF Abeta; CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; Immunogenicity (anti-drug antibodies) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 175
Study Start Date: December 2008
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PF-04360365 0.1 mg/kg: Experimental
Intervention: Biological: PF-04360365 0.1 mg/kg
Biological: PF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kg: Experimental
Intervention: Biological: PF-04360365 0.5 mg/kg
Biological: PF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kg: Experimental
Intervention: Biological: PF-04360365 1 mg/kg
Biological: PF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
Placebo: Placebo Comparator
Intervention: Drug: Placebo
Drug: Placebo
Placebo every 60 days (10 doses total)
PF-04360365 3 mg/kg: Experimental
Intervention: Biological: PF-04360365 3 mg/kg
Biological: PF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kg: Experimental
Intervention: Biological: PF-04360365 8.5 mg/kg
Biological: PF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
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 criterial 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: NCT00722046
Show 38 Study Locations
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: NCT00722046 History of Changes
Other Study ID Numbers: A9951002
Study First Received: July 23, 2008
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration
Keywords provided by Pfizer:
Alzheimer's disease
antibody
amyloid
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
