A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: PF-04360365 10 mg/kg; Biological: PF-04360365 7.5 mg/kg; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945672

2009-011172-30 (EudraCT Number)

PIB/PET IMAGING (Other Identifier)

A9951007

Details and patient eligibility

About

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.

Enrollment: 36 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females of non childbearing potential, age > or = 50.

• 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).
  • Diagnostic and Statistical Manual of Mental Disorders (DSM IV).

• Mini-mental status exam score of 16-26 inclusive.

• Rosen-Modified Hachinski Ischemia Score of < or = 4.

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.

Trial design

36 participants in 3 patient groups, including a placebo group

PF-04360365 10 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 10 mg/kg

PF-04360365 7.5 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 7.5 mg/kg

placebo

Placebo Comparator group

Treatment:

Drug: placebo