A Study Of Oral PF-01913539 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 demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).

Official Title
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A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

Conditions
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Alzheimer's Disease, Dementia, Dimebon, Investigational Drug

Intervention / Treatment
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* Drug: PF-01913539 5 mg
* Drug: PF-01913539 5 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild-to-Moderate Alzheimer's disease MMSE score 10-24 inclusive Exclusion Criteria: Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days Complication of other causes of dementia

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-01913539 5 mg three times daily<br>PF-01913539 5 mg three times daily for 6 months | Drug: PF-01913539 5 mg<br>* PF-01913539 5 mg three times daily for 6 months<br>|
| Experimental: PF-01913539 20 mg three times daily<br>PF-01913539 20 mg three times daily for 6 months | Drug: PF-01913539 5 mg<br>* PF-01913539 5 mg three times daily for 6 months<br>|
| Placebo Comparator: Placebo<br>Placebo three times daily for 6 months | Drug: Placebo<br>* Placebo three times daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline. |  | 26 weeks | 
| Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline. |  | 12, 26 weeks | 
| Mean change in Neuropsychiatric Inventory (NPI) score from baseline. |  | 12, 26 weeks | 
| Mean change in Mini-Mental State Examination (MMSE) score from baseline. |  | 6, 12, 18, 26 weeks | 
| Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline. |  | 12, 26 weeks | 
| Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis). |  | 12, 26 weeks | 
| Population PK parameters (CL/F, V/F, etc.) |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, clinical trial, memory loss, investigational drug, neurodegenerative disease, dementia