Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: PF-04360365 1 mg/kg; Biological: PF-04360365 3 mg/kg; Biological: PF-04360365 5 mg/kg; Biological: PF-04360365 10 mg/kg

• Registration Number: NCT00733642
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-13
• Status Verified: 2009-07
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2009-07-24
• Last Update Posted: 2009-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04360365 1 mg/kg	PF-04360365 1 mg/kg	-
PF-04360365 3 mg/kg	PF-04360365 3 mg/kg	-
PF-04360365 5 mg/kg	PF-04360365 5 mg/kg	-
PF-04360365 10 mg/kg	PF-04360365 10 mg/kg	-

Primary Outcome Measures

Name	Time	Method
To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Oakhurst, New Jersey, United States