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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-06

Study Completion Date

2011-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-04360365 10 mg/kg

Group Type EXPERIMENTAL

PF-04360365 10 mg/kg

Intervention Type BIOLOGICAL

10 mg/kg every 90 days (5 total doses)

PF-04360365 7.5 mg/kg

Group Type EXPERIMENTAL

PF-04360365 7.5 mg/kg

Intervention Type BIOLOGICAL

10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo administered every 90 days or monthly to match experimental treatment arms.

Interventions

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PF-04360365 10 mg/kg

10 mg/kg every 90 days (5 total doses)

Intervention Type BIOLOGICAL

PF-04360365 7.5 mg/kg

10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)

Intervention Type BIOLOGICAL

placebo

placebo administered every 90 days or monthly to match experimental treatment arms.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No