Will data on this come out at ICAD 2011?
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.
Condition Intervention Phase
Alzheimer's Disease
Biological: PF-04360365 10 mg/kg
Biological: PF-04360365 7.5 mg/kg
Drug: placebo
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 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.
