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A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

This study has been completed.
Sponsor:
Collaborator:
Trans Tech Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00141661
First received: August 30, 2005
Last updated: August 19, 2009
Last verified: August 2009
History of Changes
  Purpose

A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer Disease
 Drug: PF-04494700 - Low Dose Arm
Drug: PF-04494700 - High Dose Arm
Drug: Placebo Comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study in Subjects With Mild to Moderate Dementia of the Alzheimer's Type to Evaluate the Safety and Tolerability of Two 10-Week Dose Regimens of Orally-Administered PF-04494700

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety Measures include Adverse Events [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]
  • Laboratory Tests [ Time Frame: Every Office Visit ] [ Designated as safety issue: Yes ]
  • 12-Lead Electrocardiogram [ Time Frame: Every Office Visit ]
  • 24-Hour 12-Lead Serial ECGs [ Time Frame: Baseline, Study End ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surrogate Efficacy Markers in Plasma: A-Beta, C-Reactive Protein, IL-1, IL-6, Isoprostanes, TNF-alpha, TNF-beta [ Time Frame: Baseline, Visit 5, Study End ] [ Designated as safety issue: No ]
  • Cognitive Function Tests: ADAS-Cog, CDR-Sum of Boxes, MMSE, ADCS-ADL [ Time Frame: Screening Visit, Baseline, Study End ] [ Designated as safety issue: No ]
  • Pharmacokinetic Profile [ Time Frame: Baseline and Every Office Visit ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Arm Drug: PF-04494700 - Low Dose Arm
30 mg loading dose for 6 days, followed by 10 mg daily
Experimental: High Dose Arm Drug: PF-04494700 - High Dose Arm
60 mg loading dose for 6 days, followed by 20 mg daily
Placebo Comparator: Placebo Control Drug: Placebo Comparator
Matching placebo.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of probably Alzheimer's disease for at least 1 year.
  • Mini Mental State Exam (MMSE) score between 12-26 at screening.
  • Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.

Exclusion Criteria:

  • Current evidence of a neurological or psychiatric illness that could contribute to dementia.
  • Living alone.
  • Poorly controlled high blood pressure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141661

Locations
United States, Arizona
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Francisco, California, United States, 94118
United States, Florida
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33321
Pfizer Investigational Site
Fort Myers, Florida, United States, 33912
Pfizer Investigational Site
Hallandale Beach, Florida, United States, 33009
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Largo, Florida, United States, 33773
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
West palm Beach, Florida, United States, 33407
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Pfizer
Trans Tech Pharmaceuticals
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: NCT00141661     History of Changes
Other Study ID Numbers: B0341008, TTP488-201
Study First Received: August 30, 2005
Last Updated: August 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Interventional, Alzheimer, Safety and Tolerability

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 22, 2013