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

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005862
• Other study ID #: A9951011
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2009
• Last updated: September 25, 2012
• Start date: March 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• PF-04360365
10 mg/kg, single dose administered intravenously

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Pfizer Investigational Site	Stockholm
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional Clearance rate of ABeta peptide in CSF		36 hours	No
Secondary	Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion		36 hours	No
Secondary	PF-04360365 concentrations and ABETA concentrations in plasma and CSF		36 hours	No
Secondary	Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration		36 hours	No
Secondary	Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI		6 months	Yes

External Links

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