A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Donepezil (Aricept)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Probable or possible Alzheimer's disease
- Living in skilled nursing home
Exclusion Criteria:
- Other types of dementia or psychiatric or neurologic disorders
- Musculoskeletal disease
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
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- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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
Change from baseline in Severe Impairment Battery (SIB) total score
Secondary Outcome Measures
Change from baseline in SIB total score
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Change from inclusion in Mini Mental State Examination (MMSE) total score
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
Adverse events and laboratory value changes
Change from baseline in modified ADCS-ADL-severe total score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00630851
Brief Title
A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Donepezil (Aricept)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets orally once daily for 6 months
Primary Outcome Measure Information:
Title
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
Time Frame
Month 6
Title
Change from baseline in Severe Impairment Battery (SIB) total score
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change from baseline in SIB total score
Time Frame
Month 3
Title
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Time Frame
Months 3 and 6
Title
Change from inclusion in Mini Mental State Examination (MMSE) total score
Time Frame
Month 6
Title
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
Time Frame
Months 3 and 6
Title
Adverse events and laboratory value changes
Time Frame
Months 3 and 6
Title
Change from baseline in modified ADCS-ADL-severe total score
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Probable or possible Alzheimer's disease
Living in skilled nursing home
Exclusion Criteria:
Other types of dementia or psychiatric or neurologic disorders
Musculoskeletal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Akersberga
ZIP/Postal Code
184 33 AKERSBERGA
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Alunda
ZIP/Postal Code
747 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Aneby
ZIP/Postal Code
578 21
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Arsta
ZIP/Postal Code
120 54
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Avesta
ZIP/Postal Code
774 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bengtsfors
ZIP/Postal Code
666 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bergsjo
ZIP/Postal Code
820 70
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Boden
ZIP/Postal Code
931 64
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Borlange
ZIP/Postal Code
781 27
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Degerfors
ZIP/Postal Code
693 22
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Eskilstuna
ZIP/Postal Code
632 23
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Fritsla
ZIP/Postal Code
510 29
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Gislaved
ZIP/Postal Code
332 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
412 75
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Gullspang
ZIP/Postal Code
547 31
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Gustavsberg
ZIP/Postal Code
134 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Hedemora
ZIP/Postal Code
776 28
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Helsingborg
ZIP/Postal Code
254 43
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Ingelstad
ZIP/Postal Code
360 44
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Jönköping
ZIP/Postal Code
553 16
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kalix
ZIP/Postal Code
952 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Karlstad
ZIP/Postal Code
656 37
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Katrineholm
ZIP/Postal Code
641 47
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kristinehamn
ZIP/Postal Code
681 29
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lidkoping
ZIP/Postal Code
531 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Munkfors
ZIP/Postal Code
684 23
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Nassjo
ZIP/Postal Code
576 81
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Ostersund
ZIP/Postal Code
831 31
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Oxie
ZIP/Postal Code
238 40
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Partille
ZIP/Postal Code
43323
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Rattvik
ZIP/Postal Code
795 21
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sandviken
ZIP/Postal Code
811 60
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Saro
ZIP/Postal Code
429 13
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sjuntorp
ZIP/Postal Code
460 20
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sollebrunn
ZIP/Postal Code
466 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
112 35
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
116 32
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sunne
ZIP/Postal Code
686 22
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Trollhattan
ZIP/Postal Code
461 59
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Tullinge
ZIP/Postal Code
146 31
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Tyreso
ZIP/Postal Code
13521
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Upplands Väsby
ZIP/Postal Code
194 04
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 25
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Varnamo
ZIP/Postal Code
33185
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vaxjo
ZIP/Postal Code
352 41
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Visby
ZIP/Postal Code
621 84
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vännäs
ZIP/Postal Code
911 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Västerås
ZIP/Postal Code
722 11
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Växjö
ZIP/Postal Code
350 04
Country
Sweden
Facility Name
Pfizer Investigational Site
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2501017&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20Aricept%20in%20patients%20with%20severe%20Alzheimer%27s%20disease%20who%20are%20living%20in%20skilled%20nursing%20homes
Description
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Learn more about this trial
A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
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