A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility
1 other identifier
interventional
249
1 country
52
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 alzheimer-disease
Started Oct 2002
Shorter than P25 for phase_3 alzheimer-disease
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedMarch 5, 2015
March 1, 2015
February 27, 2008
March 4, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
Month 6
Change from baseline in Severe Impairment Battery (SIB) total score
Month 6
Secondary Outcomes (6)
Change from baseline in SIB total score
Month 3
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Months 3 and 6
Change from inclusion in Mini Mental State Examination (MMSE) total score
Month 6
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
Months 3 and 6
Adverse events and laboratory value changes
Months 3 and 6
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment
Eligibility Criteria
You may qualify if:
- Probable or possible Alzheimer's disease
- Living in skilled nursing home
You may not qualify if:
- Other types of dementia or psychiatric or neurologic disorders
- Musculoskeletal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (53)
Pfizer Investigational Site
Fritsla, Sweden, 510 29, Sweden
Pfizer Investigational Site
Alunda, 747 30, Sweden
Pfizer Investigational Site
Aneby, 578 21, Sweden
Pfizer Investigational Site
Avesta, 774 82, Sweden
Pfizer Investigational Site
Åkersberga, 184 33 AKERSBERGA, Sweden
Pfizer Investigational Site
Årsta, 120 54, Sweden
Pfizer Investigational Site
Bengtsfors, 666 30, Sweden
Pfizer Investigational Site
Bergsjö, 820 70, Sweden
Pfizer Investigational Site
Boden, 931 64, Sweden
Pfizer Investigational Site
Borlänge, 781 27, Sweden
Pfizer Investigational Site
Degerfors, 693 22, Sweden
Pfizer Investigational Site
Eskilstuna, 631 88, Sweden
Pfizer Investigational Site
Eskilstuna, 632 23, Sweden
Pfizer Investigational Site
Gislaved, 332 30, Sweden
Pfizer Investigational Site
Gothenburg, 412 75, Sweden
Pfizer Investigational Site
Gullspång, 547 31, Sweden
Pfizer Investigational Site
Gustavsberg, 134 30, Sweden
Pfizer Investigational Site
Hedemora, 776 28, Sweden
Pfizer Investigational Site
Helsingborg, 254 43, Sweden
Pfizer Investigational Site
Ingelstad, 360 44, Sweden
Pfizer Investigational Site
Jönköping, 553 16, Sweden
Pfizer Investigational Site
Kalix, 952 82, Sweden
Pfizer Investigational Site
Karlstad, 656 37, Sweden
Pfizer Investigational Site
Katrineholm, 641 47, Sweden
Pfizer Investigational Site
Kristinehamn, 681 29, Sweden
Pfizer Investigational Site
Lidköping, 531 85, Sweden
Pfizer Investigational Site
Malmo, 205 02, Sweden
Pfizer Investigational Site
Munkfors, 684 23, Sweden
Pfizer Investigational Site
Nässjö, 576 81, Sweden
Pfizer Investigational Site
Oxie, 238 40, Sweden
Pfizer Investigational Site
Östersund, 831 31, Sweden
Pfizer Investigational Site
Partille, 43323, Sweden
Pfizer Investigational Site
Rättvik, 795 21, Sweden
Pfizer Investigational Site
Sandviken, 811 60, Sweden
Pfizer Investigational Site
Särö, 429 13, Sweden
Pfizer Investigational Site
Sjuntorp, 460 20, Sweden
Pfizer Investigational Site
Sollebrunn, 466 30, Sweden
Pfizer Investigational Site
Stockholm, 112 35, Sweden
Pfizer Investigational Site
Stockholm, 116 32, Sweden
Pfizer Investigational Site
Sunne, 686 22, Sweden
Pfizer Investigational Site
Trollhättan, 461 59, Sweden
Pfizer Investigational Site
Tullinge, 146 31, Sweden
Pfizer Investigational Site
Tyreso, 13521, Sweden
Pfizer Investigational Site
Umeå, 901 85, Sweden
Pfizer Investigational Site
Upplands Vasby, 194 04, Sweden
Pfizer Investigational Site
Uppsala, 751 25, Sweden
Pfizer Investigational Site
Vaxjo, 350 04, Sweden
Pfizer Investigational Site
Vaxjo, 352 41, Sweden
Pfizer Investigational Site
Vännäs, 911 82, Sweden
Pfizer Investigational Site
Värnamo, 33185, Sweden
Pfizer Investigational Site
Västerås, 722 11, Sweden
Pfizer Investigational Site
Visby, 621 84, Sweden
Pfizer Investigational Site
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 7, 2008
Study Start
October 1, 2002
Study Completion
October 1, 2004
Last Updated
March 5, 2015
Record last verified: 2015-03