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

September 8, 2005
July 20, 2009
June 2005
April 2008   (final data collection date for primary outcome measure)
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 ]
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).
Complete list of historical versions of study NCT00174382 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Not Provided
Not Provided
 
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dementia, Vascular
  • Dementia, Mixed
Drug: Donepezil
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
Experimental: 1
Intervention: Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
149
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00174382
A2501026
No
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

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