Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease
1 other identifier
interventional
15
1 country
3
Brief Summary
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJuly 28, 2009
July 1, 2009
11 months
August 11, 2008
July 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.
6 months
Secondary Outcomes (2)
To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.
6 months
To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure.
6 months
Study Arms (4)
PF-04360365 1 mg/kg
EXPERIMENTALPF-04360365 3 mg/kg
EXPERIMENTALPF-04360365 5 mg/kg
EXPERIMENTALPF-04360365 10 mg/kg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
- Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
- MMSE score of 16-26 inclusive.
- Rosen-Modified Hachinski Ischemia Score ≤4.
- On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.
You may not qualify if:
- Diagnosis or history of other dementia 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.
- History of allergic or anaphylactic reactions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Pfizer Investigational Site
Glendale, California, 91206, United States
Pfizer Investigational Site
Eatontown, New Jersey, 07724, United States
Pfizer Investigational Site
Oakhurst, New Jersey, 07755, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 13, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
July 28, 2009
Record last verified: 2009-07