Single Dose Escalation Study of PF-04360365 In Subjects 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 single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.

Official Title
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An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: PF-04360365 1 mg/kg
* Biological: PF-04360365 3 mg/kg
* Biological: PF-04360365 5 mg/kg
* Biological: PF-04360365 10 mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (of non-child bearing potential) subjects ages ≥50 years of age. Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR. MMSE score of 16-26 inclusive. Rosen-Modified Hachinski Ischemia Score ≤4. On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing. 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. 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04360365 1 mg/kg<br> | Biological: PF-04360365 1 mg/kg<br>* PF-04360365 1 mg/kg infused as a single dose<br>|
| Experimental: PF-04360365 3 mg/kg<br> | Biological: PF-04360365 3 mg/kg<br>* PF-04360365 3 mg/kg infused as a single dose<br>|
| Experimental: PF-04360365 5 mg/kg<br> | Biological: PF-04360365 5 mg/kg<br>* PF-04360365 5 mg/kg infused as a single dose<br>|
| Experimental: PF-04360365 10 mg/kg<br> | Biological: PF-04360365 10 mg/kg<br>* PF-04360365 10 mg/kg infused as a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety and tolerability of a single dose of PF-04360365 in subjects with mild-to-moderate AD. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD. |  | 6 months | 
| To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure. |  | 6 months | 

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