Trial record 15 of 1969 for:
"Dementia"
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
This study has been terminated.
(See Detailed Description)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174382
First received: September 8, 2005
Last updated: July 20, 2009
Last verified: July 2009
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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 ]
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 ]
- 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 ]
| 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
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, K2G 3Y5 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K2C 3R2 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1N 5C8 | |
| 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: | July 20, 2009 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Dementia Dementia, Vascular Delirium, Dementia, Amnestic, Cognitive Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Mental Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013