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

Participant Flow

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
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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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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 [ Baseline, week 12, week 24 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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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 ]

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	> = 5%

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.

Other Adverse Events

	Donepezil
Total, other (not including serious) adverse events
# participants affected	53
Gastrointestinal disorders
Diarrhoea ^†^A # participants affected / at risk	15/148 (10.14%)
Nausea ^† # participants affected / at risk	26/148 (17.57%)
Vomiting ^† # participants affected / at risk	9/148 (6.08%)
Metabolism and nutrition disorders
Anorexia ^† # participants affected / at risk	8/148 (5.41%)
Nervous system disorders
Dizziness ^† # participants affected / at risk	11/148 (7.43%)
Headache ^† # participants affected / at risk	8/148 (5.41%)
Psychiatric disorders
Insomnia ^† # participants affected / at risk	15/148 (10.14%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA v11.1

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