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

Completed · Phase 1

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00733642

Run by

Pfizer

People needed

15

Starts

2008-08-01

Expected to finish

2009-07-01

Last updated by the study team

2009-07-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Pfizer Investigational Site — Glendale, California, United States
• Pfizer Investigational Site — Eatontown, New Jersey, United States
• Pfizer Investigational Site — Oakhurst, New Jersey, United States

Full record on ClinicalTrials.gov

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