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

Dementia, Vascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00174382
• Other study ID #: A2501026
• Status: Terminated
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: March 4, 2015
• Start date: June 2005
• Est. completion date: April 2008

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 149
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia, Mixed
• Dementia, Vascular

Intervention

Drug:
• Donepezil
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Abbotsford	British Columbia
Canada	Pfizer Investigational Site	Amherst	Nova Scotia
Canada	Pfizer Investigational Site	Beauport	Quebec
Canada	Pfizer Investigational Site	Belvedere	Alberta
Canada	Pfizer Investigational Site	Burlington	Ontario
Canada	Pfizer Investigational Site	Coquitlam	British Columbia
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Cowansville	Quebec
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Fort Erie	Ontario
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Hawkesbury	Ontario
Canada	Pfizer Investigational Site	L'Ancienne-Lorette	Quebec
Canada	Pfizer Investigational Site	Montréal	Quebec
Canada	Pfizer Investigational Site	North Bay	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Peterborough	Ontario
Canada	Pfizer Investigational Site	Pictou	Nova Scotia
Canada	Pfizer Investigational Site	Regina	Saskatchewan
Canada	Pfizer Investigational Site	Rimouski	Quebec
Canada	Pfizer Investigational Site	Saint John	New Brunswick
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	St-Jean-sur-Richelieu	Quebec
Canada	Pfizer Investigational Site	St. Leonard	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set	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.	Baseline, week 12, week 24	No
Secondary	Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.	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.	Baseline, week 12, week 24	No
Secondary	Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.	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	Baseline, 12 weeks, 24 weeks	No
Secondary	Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)	DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.	Baseline, week 12, week 24	No
Secondary	Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)	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.	Baseline, 12 weeks, 24 weeks	No
Secondary	Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)	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.	Baseline, 12 weeks, 24 weeks	No
Secondary	CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)	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.	Baseline, 12 weeks, 24 weeks	No
Secondary	Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)	The number of words a particpant can generate in 1 minute.	Baseline, 12 weeks, week 24	No
Secondary	Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)	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	Baseline, 12 weeks, 24 weeks	No
Secondary	Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)	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	Baseline, week 12, week 24	No
Secondary	Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)	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	Baseline, week 24	No
Secondary	Clinical Global Impressions Severity (CGI-S)	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).	Baseline	No
Secondary	Clinical Global Impressions Improvement (CGI-I)	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	Week (wk) 24	No
Secondary	Clinical Global Impressions Improvement (CGI-I) Dichotomized Response	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	Baseline, week 24	No

External Links

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