A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease

This study has been terminated.
(This study terminated 27Apr2010 due to slow recruitment and the need to use the existing information to determine dosing for another study.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01028911
First received: December 7, 2009
Last updated: May 16, 2014
Last verified: May 2014
Results First Received: April 9, 2014  
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
Condition: Alzheimer's Disease
Interventions: Drug: PF-03654746
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who were on a stable dose of donepezil (Aricept) 10 milligram (mg) once daily for at least 30 days before screening and on stable morning dosing at least 14 days before Day 0 were enrolled in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PF-03654746 and Donepezil PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
Placebo and Donepezil Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.

Participant Flow:   Overall Study
    PF-03654746 and Donepezil     Placebo and Donepezil  
STARTED     7     2  
COMPLETED     7     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all participants who took at least 1 dose of study drug.

Reporting Groups
  Description
PF-03654746 and Donepezil PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
Placebo and Donepezil Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
Total Total of all reporting groups

Baseline Measures
    PF-03654746 and Donepezil     Placebo and Donepezil     Total  
Number of Participants  
[units: participants]
  7     2     9  
Age, Customized  
[units: participants]
     
45 to 64 years     1     0     1  
Greater than or equal to (>=) 65 years     6     2     8  
Gender  
[units: participants]
     
Female     1     0     1  
Male     6     2     8  



  Outcome Measures
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1.  Primary:   Number of Participants With Clinically Significant Vital Sign Abnormalities   [ Time Frame: Baseline up to 7 to 10 days after last dose ]

2.  Primary:   Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities   [ Time Frame: Baseline up to 7 to 10 days after last dose ]

3.  Primary:   Number of Participants With Clinically Significant Laboratory Test Abnormalities   [ Time Frame: Baseline up to 7 to 10 days after last dose ]

4.  Primary:   Number of Participants With Clinically Significant Change From Baseline in Physical Examination   [ Time Frame: Baseline up to 7 to 10 days after last dose ]

5.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline   [ Time Frame: Baseline ]

6.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5   [ Time Frame: Day 5 ]

7.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10   [ Time Frame: Day 10 ]

8.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15   [ Time Frame: Day 15 ]

9.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20   [ Time Frame: Day 20 ]

10.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25   [ Time Frame: Day 25 ]

11.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 30   [ Time Frame: Day 30 ]

12.  Primary:   Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Follow-up   [ Time Frame: Follow-up (7 to 10 days after last dose) ]

13.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 5   [ Time Frame: Baseline, Day 5 ]

14.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 10   [ Time Frame: Baseline, Day 10 ]

15.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 15   [ Time Frame: Baseline, Day 15 ]

16.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 20   [ Time Frame: Baseline, Day 20 ]

17.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 25   [ Time Frame: Baseline, Day 25 ]

18.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Day 30   [ Time Frame: Baseline, Day 30 ]

19.  Primary:   Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Follow-up   [ Time Frame: Baseline, Follow-up (7 to 10 days after last dose) ]

20.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 5   [ Time Frame: Baseline, Day 5 ]

21.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 10   [ Time Frame: Baseline, Day 10 ]

22.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 15   [ Time Frame: Baseline, Day 15 ]

23.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 20   [ Time Frame: Baseline, Day 20 ]

24.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 25   [ Time Frame: Baseline, Day 25 ]

25.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Day 30   [ Time Frame: Baseline, Day 30 ]

26.  Primary:   Change From Baseline in Mini Mental State Examination (MMSE) Total Score at Follow-up   [ Time Frame: Baseline, Follow-up (7 to 10 days after last dose) ]

27.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-03654746   [ Time Frame: 0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30 ]

28.  Secondary:   Maximum Serum Concentration (Cmax) for PF-03654746   [ Time Frame: 0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30 ]

29.  Secondary:   Time to Reach Maximum Observed Serum Concentration (Tmax) for PF-03654746   [ Time Frame: 0 hour (pre-dose), 0.5, 1, 3, 8 and 12 hours post-dose on Day 30 ]

30.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Donepezil   [ Time Frame: 0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30 ]

31.  Secondary:   Maximum Plasma Concentration (Cmax) for Donepezil   [ Time Frame: 0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30 ]

32.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) for Donepezil   [ Time Frame: 0 hour (pre-dose), 0.5, 1, 3, 8, 12 hours post-dose on Day 0, Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early due to slow recruitment and the need to use the existing information to determine dosing for another study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01028911     History of Changes
Other Study ID Numbers: A8801016
Study First Received: December 7, 2009
Results First Received: April 9, 2014
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration