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

Condition(s) targeted: Dementia, Vascular; Dementia, Mixed

Intervention: Donepezil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To evaluate whether donepezil will increase general cognition as measured by the SMMSE in subjects with vascular dementia and mixed dementia (Alzheimer's disease/Vascular Dementia).

Secondary outcome: To evaluate the safety of donepezil , as well as its effect on executive functioning, behavior, and ADLs in subjects with vascular and mixed dementia (Alzheimer's disease/Vascular dementia).

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer Investigational Site, Belvedere, Alberta T5C 0A3, Canada

Pfizer Investigational Site, Edmonton, Alberta T5A 4L8, Canada

Pfizer Investigational Site, Edmonton, Alberta T6A 0A5, Canada

Pfizer Investigational Site, Coquitlam, British Columbia V3K 3P4, Canada

Pfizer Investigational Site, Victoria, British Columbia V8T 5G1, Canada

Pfizer Investigational Site, Abbotsford, British Columbia V2S 3P8, Canada

Pfizer Investigational Site, Winnipeg, Manitoba R2H 0R8, Canada

Pfizer Investigational Site, Saint John, New Brunswick E2L 3L6, Canada

Pfizer Investigational Site, Pictou, Nova Scotia B0K 1H0, Canada

Pfizer Investigational Site, Amherst, Nova Scotia B4H 4R7, Canada

Pfizer Investigational Site, Halifax, Nova Scotia B3H 2E1, Canada

Pfizer Investigational Site, Fort Erie, Ontario L2A 1Z3, Canada

Pfizer Investigational Site, North Bay, Ontario P1B 2H3, Canada

Pfizer Investigational Site, Sarnia, Ontario N7T 4X3, Canada

Pfizer Investigational Site, Corunna, Ontario N0N 1G0, Canada

Pfizer Investigational Site, Burlington, Ontario L7M 4Y1, Canada

Pfizer Investigational Site, Ottawa, Ontario K2G 3Y5, Canada

Pfizer Investigational Site, Hawkesbury, Ontario K6A 1A1, Canada

Pfizer Investigational Site, Ottawa, Ontario K2C 3R2, Canada

Pfizer Investigational Site, Toronto, Ontario M3B 2W7, Canada

Pfizer Investigational Site, Ottawa, Ontario K1N 5C8, Canada

Pfizer Investigational Site, Peterborough, Ontario K9H 2P4, Canada

Pfizer Investigational Site, St-Jean-sur-Richelieu, Quebec J2W 2A3, Canada

Pfizer Investigational Site, L'Ancienne-Lorette, Quebec G2E 2X1, Canada

Pfizer Investigational Site, Cowansville, Quebec J2K 2X9, Canada

Pfizer Investigational Site, Rimouski, Quebec G5L 9A8, Canada

Pfizer Investigational Site, St. Leonard, Quebec H1S 3A9, Canada

Pfizer Investigational Site, Montréal, Quebec H1T 2M4, Canada

Pfizer Investigational Site, Beauport, Quebec G1J 2G3, Canada

Pfizer Investigational Site, Regina, Saskatchewan S4P 3X1, Canada

To obtain contact information for a study center near you, click here.

Starting date: June 2005
Ending date: April 2008
Last updated: June 2, 2008