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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Biological: PF-04360365 5 mg/kg; Biological: PF-04360365 10 mg/kg; Biological: PF-04360365 1 mg/kg; Biological: PF-04360365 3 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00733642

A9951008

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 4 patient groups

PF-04360365 1 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 1 mg/kg

PF-04360365 3 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 3 mg/kg

PF-04360365 5 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 5 mg/kg

PF-04360365 10 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 10 mg/kg