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

Study Overview
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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.

Official Title
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A Phase 2 Double-Blinded, Randomized, Placebo-Controlled, Multicenter Study Evaluating The Safety, Tolerability And Pharmacokinetics/ Pharmacodynamics Of PF-04360365 In Mild To Moderate Alzheimer's Disease Patients

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: PF-04360365 10 mg/kg
* Biological: PF-04360365 7.5 mg/kg
* Drug: placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04360365 10 mg/kg<br> | Biological: PF-04360365 10 mg/kg<br>* 10 mg/kg every 90 days (5 total doses)<br>|
| Experimental: PF-04360365 7.5 mg/kg<br> | Biological: PF-04360365 7.5 mg/kg<br>* 10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo administered every 90 days or monthly to match experimental treatment arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability/PK of multiple doses of PF-04360365 in subjects with mild to moderate Alzheimer's disease dosed for 1 year (adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical labs, brain MRI, cognitive assessments) |  | 18 months | 
| Brain amyloid burden |  | 13 months | 
| CSF abeta |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog); Disability Assessment for Dementia (DAD); plasma abeta, CSF tau and phosphotau; CSF protein, RBCs, WBCs and glucose; immunogenicity (anti-drug antibodies) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease amyloid imaging antibody