Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174382
First received: September 8, 2005
Last updated: July 20, 2009
Last verified: July 2009
Results First Received: April 24, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Dementia, Vascular
Dementia, Mixed
Intervention: Drug: Donepezil

  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
Study was conducted in Canada in 30 centres.

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
Donepezil Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.

Participant Flow:   Overall Study
    Donepezil  
STARTED     149 [1]
COMPLETED     116  
NOT COMPLETED     33  
Death                 2  
Adverse Event                 19  
Withdrawal by Subject                 6  
Protocol Violation                 3  
Arrived early for last visit in error                 1  
Subject felt pill not effective enough                 1  
Lost to Follow-up                 1  
[1] 148 are summarized below: 1 subject entered the study but was lost to follow up.



  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.
No text entered.

Reporting Groups
  Description
Donepezil Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.

Baseline Measures
    Donepezil  
Number of Participants  
[units: participants]
  149  
Age, Customized  
[units: Participants]
 
< 45     0  
45-64     20  
>= 65     129  
Gender  
[units: participants]
 
Female     82  
Male     67  



  Outcome Measures
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1.  Primary:   Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set   [ Time Frame: Baseline, week 12, week 24 ]

2.  Secondary:   Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.   [ Time Frame: Baseline, week 12, week 24 ]

3.  Secondary:   Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

4.  Secondary:   Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)   [ Time Frame: Baseline, week 12, week 24 ]

5.  Secondary:   Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

6.  Secondary:   Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

7.  Secondary:   CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

8.  Secondary:   Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)   [ Time Frame: Baseline, 12 weeks, week 24 ]

9.  Secondary:   Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)   [ Time Frame: Baseline, 12 weeks, 24 weeks ]

10.  Secondary:   Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)   [ Time Frame: Baseline, week 12, week 24 ]

11.  Secondary:   Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)   [ Time Frame: Baseline, week 24 ]

12.  Secondary:   Clinical Global Impressions Severity (CGI-S)   [ Time Frame: Baseline ]

13.  Secondary:   Clinical Global Impressions Improvement (CGI-I)   [ Time Frame: Week (wk) 24 ]

14.  Secondary:   Clinical Global Impressions Improvement (CGI-I) Dichotomized Response   [ Time Frame: Baseline, week 24 ]


  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
No text entered.


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00174382     History of Changes
Other Study ID Numbers: A2501026
Study First Received: September 8, 2005
Results First Received: April 24, 2009
Last Updated: July 20, 2009
Health Authority: Canada: Health Canada