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
  Purpose

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.


Condition Intervention Phase
Dementia, Vascular
Dementia, Mixed
Drug: Donepezil
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 149
Study Start Date: June 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Donepezil
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174382

Locations
Canada, Alberta
Pfizer Investigational Site
Belvedere, Alberta, Canada, T5C 0A3
Pfizer Investigational Site
Edmonton, Alberta, Canada, T5A 4L8
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6A 0A5
Canada, British Columbia
Pfizer Investigational Site
Abbotsford, British Columbia, Canada, V2S 3P8
Pfizer Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Pfizer Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R2H 0R8
Canada, New Brunswick
Pfizer Investigational Site
Saint John, New Brunswick, Canada, E2L 3L6
Canada, Nova Scotia
Pfizer Investigational Site
Amherst, Nova Scotia, Canada, B4H 4R7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2E1
Pfizer Investigational Site
Pictou, Nova Scotia, Canada, B0K 1H0
Canada, Ontario
Pfizer Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Pfizer Investigational Site
Corunna, Ontario, Canada, N0N 1G0
Pfizer Investigational Site
Fort Erie, Ontario, Canada, L2A 1Z3
Pfizer Investigational Site
Hawkesbury, Ontario, Canada, K6A 1A1
Pfizer Investigational Site
North Bay, Ontario, Canada, P1B 2H3
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1N 5C8
Pfizer Investigational Site
Ottawa, Ontario, Canada, K2C 3R2
Pfizer Investigational Site
Ottawa, Ontario, Canada, K2G 3Y5
Pfizer Investigational Site
Peterborough, Ontario, Canada, K9H 2P4
Pfizer Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Pfizer Investigational Site
Toronto, Ontario, Canada, M3B 2W7
Canada, Quebec
Pfizer Investigational Site
Beauport, Quebec, Canada, G1J 2G3
Pfizer Investigational Site
Cowansville, Quebec, Canada, J2K 2X9
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
Pfizer Investigational Site
Montréal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site
Rimouski, Quebec, Canada, G5L 9A8
Pfizer Investigational Site
St-Jean-sur-Richelieu, Quebec, Canada, J2W 2A3
Pfizer Investigational Site
St. Leonard, Quebec, Canada, H1S 3A9
Canada, Saskatchewan
Pfizer Investigational Site
Regina, Saskatchewan, Canada, S4P 3X1
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00174382     History of Changes
Other Study ID Numbers: A2501026
Study First Received: September 8, 2005
Results First Received: April 24, 2009
Last Updated: March 4, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dementia
Dementia, Vascular
Delirium, Dementia, Amnestic, Cognitive Disorders
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Nervous System Diseases
Vascular Diseases
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 30, 2015