Multiple IV 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: Drug: Placebo; Biological: PF-04360365 0.1 mg/kg; Biological: PF-04360365 1 mg/kg; Biological: PF-04360365 3 mg/kg; Biological: PF-04360365 8.5 mg/kg; Biological: PF-04360365 0.5 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722046

MD IN AD PATIENT (Other Identifier)

A9951002

2008-000986-42 (EudraCT Number)

Details and patient eligibility

About

Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.

Enrollment: 198 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 criterial 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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198 participants in 6 patient groups, including a placebo group

PF-04360365 0.1 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 0.1 mg/kg

PF-04360365 0.5 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 0.5 mg/kg

PF-04360365 1 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 1 mg/kg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-04360365 3 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 3 mg/kg

PF-04360365 8.5 mg/kg

Experimental group

Treatment:

Biological: PF-04360365 8.5 mg/kg