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
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 April 23, 2014