Clinical Trial: A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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

Brief Summary: 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).

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline. [ Time Frame: 12, 26 weeks ]
  • Mean change in Neuropsychiatric Inventory (NPI) score from baseline. [ Time Frame: 12, 26 weeks ]
  • Mean change in Mini-Mental State Examination (MMSE) score from baseline. [ Time Frame: 6, 12, 18, 26 weeks ]
  • Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline. [ Time Frame: 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). [ Time Frame: 12, 26 weeks ]
  • Population PK parameters (CL/F, V/F, etc.) [ Time Frame: 26 weeks ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: February 9, 2010
Date Started: April 2010
Date Completion: April 2012
Last Updated: June 28, 2010
Last Verified: June 2010