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

October 1, 2009
August 5, 2010
October 2009
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00988598 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: PF-04447943
    25 mg of PF-04447943 orally every 12 hours for 7 days
  • Drug: Placebo
    25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days
  • Active Comparator: PF-04447943
    Intervention: Drug: PF-04447943
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00988598
B0401008
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP