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: March 4, 2015
Last verified: March 2015

September 8, 2005
March 4, 2015
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 ]
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
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 ]
    The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.
  • Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain. [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance & correspondence, medications, leisure & housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered
  • 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 ]
    DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.
  • 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 ]
    The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.
  • 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 ]
    The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.
  • CLOX Differential Score Change From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.
  • Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS) [ Time Frame: Baseline, 12 weeks, week 24 ] [ Designated as safety issue: No ]
    The number of words a particpant can generate in 1 minute.
  • 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 ]
    NPI-Q measures severity of behavioural manifestations of dementia & the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores & ranges from 0 to 36
  • 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 ]
    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
  • 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 ]
    Scale measures subject's clinical condition at baseline for severity (CGI-S) & for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline
  • Clinical Global Impressions Severity (CGI-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Scale measures subject's clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).
  • Clinical Global Impressions Improvement (CGI-I) [ Time Frame: Week (wk) 24 ] [ Designated as safety issue: No ]
    Scale measures subject's clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline
  • Clinical Global Impressions Improvement (CGI-I) Dichotomized Response [ Time Frame: Baseline, week 24 ] [ Designated as safety issue: No ]
    Scale measures subject's (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more
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
March 2015

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