A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease
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
1 other identifier
interventional
N/A
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 29, 2010
June 1, 2010
1.9 years
February 9, 2010
June 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
PF-01913539 5 mg three times daily
EXPERIMENTALPF-01913539 5 mg three times daily for 6 months
PF-01913539 20 mg three times daily
EXPERIMENTALPF-01913539 20 mg three times daily for 6 months
Placebo
PLACEBO COMPARATORPlacebo three times daily for 6 months
Interventions
PF-01913539 5 mg three times daily for 6 months
Eligibility Criteria
You may qualify if:
- Mild-to-Moderate Alzheimer's disease
- MMSE score 10-24 inclusive
You may not qualify if:
- Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
- Complication of other causes of dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2010
First Posted
February 10, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
June 29, 2010
Record last verified: 2010-06