A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.

Official Title
-----------------
A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: PF-04494700
* Drug: PF-04494700
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening. Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization Exclusion Criteria: Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia. Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations. Evidence or history of diabetes mellitus Type 1 or Type 2. History or symptoms of autoimmune disorders.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: PF-04494700<br>* 15 mg for 6 days followed by daily dosing of 5mg<br>|
| Experimental: 2<br> | Drug: PF-04494700<br>* 60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment. |  | 18 Month | 
| Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI). |  | 18 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET) |  | 18 Month | 
| Evaluate the potential dose response of PF 04494700 |  | 18 Month | 
| Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints |  | 18 Month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RI RI Study Rage Inhibitors