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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This study has been withdrawn prior to enrollment.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
History of Changes
  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:

U.S. FDA Resources

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 May 16, 2013