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

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Conditions:	Dementia, Vascular Dementia, Mixed
Intervention:	Drug: Donepezil

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.

	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.

	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

1. Primary:

Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set [ Baseline, week 12, week 24 ]

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS) [ Baseline, week 12, week 24 ]

Show Outcome Measure 4

5. Secondary:

Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS) [ Baseline, 12 weeks, 24 weeks ]

Show Outcome Measure 5

6. Secondary:

Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS) [ Baseline, 12 weeks, 24 weeks ]

Show Outcome Measure 6

7. Secondary:

CLOX Differential Score Change From Baseline; Full Analysis Set (FAS) [ Baseline, 12 weeks, 24 weeks ]

Show Outcome Measure 7

8. Secondary:

Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS) [ Baseline, 12 weeks, week 24 ]

Show Outcome Measure 8

9. Secondary:

Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS) [ Baseline, 12 weeks, 24 weeks ]

Show Outcome Measure 9

10. Secondary:

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

Hide Outcome Measure 10

Measure Type	Secondary
Measure Title	Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
Measure Description	The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60
Time Frame	Baseline, week 12, week 24
Safety Issue	No

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.
Full Analysis Set (FAS): all subjects who received at least one dose donepezil and who have baseline and at least one post-baseline assessment of efficacy and LOCF = Last Observation Carried Forward.LOCF n=137; weeks 12, 24 n = 124, 114

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.

Measured Values

	Donepezil
Number of Participants Analyzed [units: participants]	137
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS) [units: Score on a scale] Mean ± Standard Deviation
week 12 (n=124)	-0.95 ± 5.54
week 24 (n=114)	-1.37 ± 6.25
week 24 LOCF (n=137)	-1.08 ± 6.04

Statistical Analysis 1 for Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)

Groups ^[1]	Donepezil
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.182
Mean Difference (Net) ^[4]	-0.83
Standard Error of the mean	± 0.62
95% Confidence Interval	( -2.06 to 0.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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Statistical Analysis 2 for Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)

Groups ^[1]	Donepezil
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.114
Mean Difference (Net) ^[4]	-1.09
Standard Error of the mean	± 0.68
95% Confidence Interval	( -2.44 to 0.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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Statistical Analysis 3 for Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)

Groups ^[1]	Donepezil
Method ^[2]	Mixed Models Analysis
P Value ^[3]	0.038

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

Clinical Global Impressions Severity (CGI-S) [ Baseline ]

Show Outcome Measure 12

13. Secondary:

Clinical Global Impressions Improvement (CGI-I) [ Week (wk) 24 ]

Show Outcome Measure 13

14. Secondary:

Clinical Global Impressions Improvement (CGI-I) Dichotomized Response [ Baseline, week 24 ]

Show Outcome Measure 14

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

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