A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00930059
First received: June 29, 2009
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.


Condition Intervention Phase
Alzheimer's Disease
Drug: PF-04447943
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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study Of PF-04447943 In Subjects With Mild To Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline on Alzheimer's Disease Assessment Scale (Cognitive Subscale) [ Time Frame: screen, baseline, wks 3, 6, 9, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline on Neuropsychiatric Inventory [ Time Frame: screen, baseline, wks 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Improvement [ Time Frame: wks 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Safety Assessments (including adverse events, vital signs, electrocardiograms, laboratory tests) [ Time Frame: screen, baseline, weeks 1, 3, 6, 9, 12 ] [ Designated as safety issue: Yes ]
  • Plasma Concentrations of PF-04447943 [ Time Frame: wks 1, 3, 6, 9, 12 ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04447943 Drug: PF-04447943
tablets, 25 mg every 12 hours for 12 wks
Placebo Comparator: Placebo Drug: Placebo
matching placebo tablets, every 12 hours for 12 wks

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate Alzheimer's disease (MMSE 14-26)
  • Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion Criteria:

  • Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
  • Significant cardiovascular disease in the past 6 months
  • Illness other than Alzheimer's disease that could contribute to cognitive impairment
  • History of stroke or seizure disorder
  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: NCT00930059

  Show 43 Study Locations
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: NCT00930059     History of Changes
Other Study ID Numbers: B0401005
Study First Received: June 29, 2009
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Alzheimer's disease
PF-04447943
efficacy
safety
plasma concentrations

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 24, 2014