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

Alzheimer's Disease Clinical Trial

Official title:

An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733642
• Other study ID #: A9951008
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2008
• Last updated: July 24, 2009
• Start date: August 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• PF-04360365 1 mg/kg
PF-04360365 1 mg/kg infused as a single dose
• PF-04360365 3 mg/kg
PF-04360365 3 mg/kg infused as a single dose
• PF-04360365 5 mg/kg
PF-04360365 5 mg/kg infused as a single dose
• PF-04360365 10 mg/kg
PF-04360365 10 mg/kg infused as a single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Eatontown	New Jersey
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Oakhurst	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD.		6 months	Yes
Secondary	To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD.		6 months	No
Secondary	To evaluate the relationship of PF-04360365 plasma exposure and Aß plasma exposure.		6 months	No

External Links

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