A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Pfizer

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Biological: PF-04360365; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00455000

A9951001

Details and patient eligibility

About

The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.

Enrollment: 37 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Females of non-childbearing potential, age 50-85
• Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
• Mini-mental status exam score of 16-26 inclusive
• Rosen-Modified Hachinski Ischemia Score < or = 4

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, extensive white matter abnormalities
• History of autoimmune disorders
• History of allergic or anaphylactic reactions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups, including a placebo group

Active treatment

Experimental group

Description:

5 possible active doses

Treatment:

Biological: PF-04360365

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo