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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

July 20, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set [ Time Frame: Baseline, week 12, week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To evaluate whether donepezil will increase general cognition as measured by the SMMSE in subjects with vascular dementia and mixed dementia (Alzheimer's disease/Vascular Dementia).

Change History

Complete list of historical versions of study NCT00174382 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain. [ Time Frame: Baseline, week 12, week 24 ] [ Designated as safety issue: No ]
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS) [ Time Frame: Baseline, week 12, week 24 ] [ Designated as safety issue: No ]
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, week 24 ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, week 12, week 24 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Clinical Global Impressions Severity (CGI-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Clinical Global Impressions Improvement (CGI-I) [ Time Frame: Week (wk) 24 ] [ Designated as safety issue: No ]
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To measure the effect of donepezil in the treatment of executive dysfunction, behavior, and ADLs in subjects with vascular dementia and mixed dementia (Alzheimer's disease/Vascular Dementia).To confirm that donepezil is safe and well tolerated in subject

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.

Detailed Description

The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dementia, Vascular
Dementia, Mixed

Intervention ^ICMJE

Drug: Donepezil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

149

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.

Exclusion Criteria:

Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00174382

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A2501026

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2009

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