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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00174382 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia |
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 |
---|---|
1: Experimental |
Drug: Donepezil
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Coquitlam, British Columbia, Canada, V3K 3P4 | |
Pfizer Investigational Site | |
Victoria, British Columbia, Canada, V8T 5G1 | |
Pfizer Investigational Site | |
Abbotsford, British Columbia, Canada, V2S 3P8 | |
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 | |
Pictou, Nova Scotia, Canada, B0K 1H0 | |
Pfizer Investigational Site | |
Amherst, Nova Scotia, Canada, B4H 4R7 | |
Pfizer Investigational Site | |
Halifax, Nova Scotia, Canada, B3H 2E1 | |
Canada, Ontario | |
Pfizer Investigational Site | |
Corunna, Ontario, Canada, N0N 1G0 | |
Pfizer Investigational Site | |
North Bay, Ontario, Canada, P1B 2H3 | |
Pfizer Investigational Site | |
Sarnia, Ontario, Canada, N7T 4X3 | |
Pfizer Investigational Site | |
Fort Erie, Ontario, Canada, L2A 1Z3 | |
Pfizer Investigational Site | |
Burlington, Ontario, Canada, L7M 4Y1 | |
Pfizer Investigational Site | |
Ottawa, Ontario, Canada, K2G 3Y5 | |
Pfizer Investigational Site | |
Hawkesbury, Ontario, Canada, K6A 1A1 | |
Pfizer Investigational Site | |
Ottawa, Ontario, Canada, K2C 3R2 | |
Pfizer Investigational Site | |
Toronto, Ontario, Canada, M3B 2W7 | |
Pfizer Investigational Site | |
Ottawa, Ontario, Canada, K1N 5C8 | |
Pfizer Investigational Site | |
Peterborough, Ontario, Canada, K9H 2P4 | |
Canada, Quebec | |
Pfizer Investigational Site | |
St-Jean-sur-Richelieu, Quebec, Canada, J2W 2A3 | |
Pfizer Investigational Site | |
L'Ancienne-Lorette, Quebec, Canada, G2E 2X1 | |
Pfizer Investigational Site | |
Cowansville, Quebec, Canada, J2K 2X9 | |
Pfizer Investigational Site | |
Rimouski, Quebec, Canada, G5L 9A8 | |
Pfizer Investigational Site | |
St. Leonard, Quebec, Canada, H1S 3A9 | |
Pfizer Investigational Site | |
Montréal, Quebec, Canada, H1T 2M4 | |
Pfizer Investigational Site | |
Beauport, Quebec, Canada, G1J 2G3 | |
Canada, Saskatchewan | |
Pfizer Investigational Site | |
Regina, Saskatchewan, Canada, S4P 3X1 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trials Disclosure Group ) |
Study ID Numbers: | A2501026 |
Study First Received: | September 8, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00174382 |
Health Authority: | Canada: Health Canada |
Arterial Occlusive Diseases Vascular Diseases Central Nervous System Diseases Arteriosclerosis Brain Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Cognition Disorders |
Intracranial Arteriosclerosis Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Dementia, Vascular Dementia Delirium |
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Enzyme Inhibitors Cardiovascular Diseases Cholinergic Agents Central Nervous System Agents Pharmacologic Actions |