Clinical trial NCT00174382: Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
Official title: An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dementia, Vascular
Dementia, Mixed
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 149
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
timeFrame: Baseline, week 12, week 24
Secondary outcomes:
measure: Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
timeFrame: Baseline, week 12, week 24
measure: Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
timeFrame: Baseline, week 12, week 24
measure: Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
timeFrame: Baseline, 12 weeks, week 24
measure: Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
timeFrame: Baseline, week 12, week 24
measure: Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
timeFrame: Baseline, week 24
measure: Clinical Global Impressions Severity (CGI-S)
timeFrame: Baseline
measure: Clinical Global Impressions Improvement (CGI-I)
timeFrame: Week (wk) 24
measure: Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
timeFrame: Baseline, week 24
Other outcomes:
Locations:
city: Belvedere
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Abbotsford
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Saint John
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Amherst
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Pictou
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Fort Erie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Beauport
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Cowansville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: L'Ancienne-Lorette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montréal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Rimouski
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Jean-sur-Richelieu
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St. Leonard
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: