Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: PF-04360365; Drug: Placebo

• Registration Number: NCT01005862
• Lead Sponsor: Pfizer

Brief Summary

The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Study Start: 2010-03
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
• For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
• Mini-mental status exam score greater than or equal to 20
• Rosen-Modified Hachinski Ischemia Score of < or = 4
• On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04360365	PF-04360365	-
Placebo	Placebo	single dose administered intravenously

Primary Outcome Measures

Name	Time	Method
Fractional Clearance rate of ABeta peptide in CSF	36 hours

Secondary Outcome Measures

Name	Time	Method
Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion	36 hours
PF-04360365 concentrations and ABETA concentrations in plasma and CSF	36 hours
Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration	36 hours
Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI	6 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Stockholm, Sweden