A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00988598
First received: October 1, 2009
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

The purpose of the study is to evaluate the safety of PF-04447943 when given in combination with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the absorption and distribution of both PF-04447943 and donepezil.


Condition Intervention Phase
Alzheimer's Disease
Drug: PF-04447943
Drug: Placebo
Phase 1

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 Phase 1, Double-Blind, Placebo-Controlled, Sponsor Open, Randomized, Multiple Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04447943 In Mild To Moderate Alzheimer's Disease Subjects On Stable Donepezil Therapy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • vital signs [ Time Frame: screening, day 0-day 7, day 10 ] [ Designated as safety issue: Yes ]
  • ECGs [ Time Frame: screening, day 0, 1, 2, 3, 4, 7, and 10 ] [ Designated as safety issue: Yes ]
  • Physical and Neurological examinations [ Time Frame: screening, days 0, 4, and 10 ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Screening, days 0, 1, 4, 7, and 10 ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: screening through study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations of PF 04447943 over time [ Time Frame: Days 1 and 7 ] [ Designated as safety issue: No ]
  • Plasma concentrations of donepezil over time [ Time Frame: days 0 and 7 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PF-04447943 Drug: PF-04447943
25 mg of PF-04447943 orally every 12 hours for 7 days
Placebo Comparator: Placebo Drug: Placebo
25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days

  Eligibility

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

Inclusion Criteria:

  • Subjects must have Alzheimer's dementia with a Mini Mental State Examination score between 18-26, inclusive.
  • Subjects must have a reliable caregiver.
  • Subjects must be on Aricept
  • Memantine is allowed if subjects are on a stable dose
  • Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG, with no serious or unstable disease within the past 3 months.

Exclusion Criteria:

  • Subjects with clinically significant heart disease cannot participate.
  • Subjects with a past or current history of seizures cannot participate.
  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: NCT00988598

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
Pfizer Investigational Site
Hallandale Beach, Florida, United States, 33009
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: NCT00988598     History of Changes
Other Study ID Numbers: B0401008
Study First Received: October 1, 2009
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
phase 1 Alzheimer's disease donepezil

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
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014