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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01066481
First received: February 9, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Dementia
Dimebon
Investigational Drug
Drug: PF-01913539 5 mg
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline. [ Time Frame: 12, 26 weeks ] [ Designated as safety issue: No ]
  • Mean change in Neuropsychiatric Inventory (NPI) score from baseline. [ Time Frame: 12, 26 weeks ] [ Designated as safety issue: No ]
  • Mean change in Mini-Mental State Examination (MMSE) score from baseline. [ Time Frame: 6, 12, 18, 26 weeks ] [ Designated as safety issue: No ]
  • Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline. [ Time Frame: 12, 26 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Population PK parameters (CL/F, V/F, etc.) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-01913539 5 mg three times daily
PF-01913539 5 mg three times daily for 6 months
Drug: PF-01913539 5 mg
PF-01913539 5 mg three times daily for 6 months
Experimental: PF-01913539 20 mg three times daily
PF-01913539 20 mg three times daily for 6 months
Drug: PF-01913539 5 mg
PF-01913539 5 mg three times daily for 6 months
Placebo Comparator: Placebo
Placebo three times daily for 6 months
Drug: Placebo
Placebo three times daily for 6 months

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066481

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01066481     History of Changes
Other Study ID Numbers: B1451010
Study First Received: February 9, 2010
Last Updated: June 28, 2010
Health Authority: JAPAN: MInistry of Health and Labor Welfare

Keywords provided by Pfizer:
Alzheimer's disease
clinical trial
memory loss
investigational drug
neurodegenerative disease
dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014