At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 198 enrolled
Drug / intervention
PF-04360365 0.1 mg/kg +5 morebiological
Likely dose
PF-04360365 0.1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating PF-04360365 0.1 mg/kg, PF-04360365 0.5 mg/kg, and 4 other interventions for Alzheimer's Disease. Completed, enrolled 198 participants across 42 sites in 6 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesAustralia, Belgium, Canada, South Korea, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2008
Enrollment StartDec 2008
Primary CompletionAug 2011
TodayJul 2026
First PostedJul 25, 2008
Enrollment StartDec 5, 2008
Primary CompletionAug 16, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.9 years ago
Interventions
PF-04360365 0.1 mg/kgbiological
0.1 mg/kg every 60 days (10 doses total)
PF-04360365 0.5 mg/kgbiological
0.5 mg/kg every 60 days (10 doses total)
PF-04360365 1 mg/kgbiological
1 mg/kg every 60 days (10 doses total)
Placebodrug
Placebo every 60 days (10 doses total)
PF-04360365 3 mg/kgbiological
3 mg/kg every 60 days (10 doses total)
PF-04360365 8.5 mg/kgbiological
8.5 mg/kg every 60 days (10 doses total)