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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01066481
• Other study ID #: B1451010
• Status: Withdrawn
• Phase: Phase 2
• First received: February 9, 2010
• Last updated: June 28, 2010
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: JAPAN: MInistry of Health and Labor Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Dimebon
• Investigational Drug

Intervention

Drug:
• PF-01913539 5 mg
PF-01913539 5 mg three times daily for 6 months
• PF-01913539 5 mg
PF-01913539 5 mg three times daily for 6 months
• Placebo
Placebo three times daily for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.		26 weeks	No
Primary	Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input		26 weeks	No
Secondary	Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.		12, 26 weeks	No
Secondary	Mean change in Neuropsychiatric Inventory (NPI) score from baseline.		12, 26 weeks	No
Secondary	Mean change in Mini-Mental State Examination (MMSE) score from baseline.		6, 12, 18, 26 weeks	No
Secondary	Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.		12, 26 weeks	No
Secondary	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	Yes
Secondary	Population PK parameters (CL/F, V/F, etc.)		26 weeks	No

External Links

•   To obtain contact information for a study center near you, click here.