A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00630851
First received: February 27, 2008
Last updated: April 22, 2011
Last verified: April 2011
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Purpose
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Donepezil (Aricept) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
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 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Change from baseline in Severe Impairment Battery (SIB) total score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in SIB total score [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
- Change from baseline in Neuropsychiatric Inventory (NPI) total score [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
- Change from inclusion in Mini Mental State Examination (MMSE) total score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
- Change from baseline in Clinical Global Impression of Improvement (CGI-I) score [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
- Adverse events and laboratory value changes [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: Yes ]
- Change from baseline in modified ADCS-ADL-severe total score [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
| Enrollment: | 249 |
| Study Start Date: | October 2002 |
| Study Completion Date: | October 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Donepezil (Aricept)
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
|
| Placebo Comparator: 2 |
Drug: Placebo
Matching placebo tablets orally once daily for 6 months
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630851
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Hide Study LocationsLocations
| Sweden | |
| Pfizer Investigational Site | |
| Varnamo, 331 85, Sweden | |
| Pfizer Investigational Site | |
| 135 21 Tyreso, Sweden | |
| Pfizer Investigational Site | |
| Akersberga, Sweden, 184 33 AKERSBERGA | |
| Pfizer Investigational Site | |
| Alunda, Sweden, 747 30 | |
| Pfizer Investigational Site | |
| Aneby, Sweden, 578 21 | |
| Pfizer Investigational Site | |
| Arsta, Sweden, 120 54 | |
| Pfizer Investigational Site | |
| Avesta, Sweden, 774 82 | |
| Pfizer Investigational Site | |
| Bengtsfors, Sweden, 666 30 | |
| Pfizer Investigational Site | |
| Bergsjo, Sweden, 820 70 | |
| Pfizer Investigational Site | |
| Boden, Sweden, 931 64 | |
| Pfizer Investigational Site | |
| Borlange, Sweden, 781 27 | |
| Pfizer Investigational Site | |
| Degerfors, Sweden, 693 22 | |
| Pfizer Investigational Site | |
| Eskilstuna, Sweden, 631 88 | |
| Pfizer Investigational Site | |
| Eskilstuna, Sweden, 632 23 | |
| Pfizer Investigational Site | |
| Fritsla, Sweden, 510 29 | |
| Pfizer Investigational Site | |
| Gislaved, Sweden, 332 30 | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 412 75 | |
| Pfizer Investigational Site | |
| Gullspang, Sweden, 547 31 | |
| Pfizer Investigational Site | |
| Gustavsberg, Sweden, 134 30 | |
| Pfizer Investigational Site | |
| Hedemora, Sweden, 776 28 | |
| Pfizer Investigational Site | |
| Helsingborg, Sweden, 254 43 | |
| Pfizer Investigational Site | |
| Ingelstad, Sweden, 360 44 | |
| Pfizer Investigational Site | |
| Jönköping, Sweden, 553 16 | |
| Pfizer Investigational Site | |
| Kalix, Sweden, 952 82 | |
| Pfizer Investigational Site | |
| Karlstad, Sweden, 656 37 | |
| Pfizer Investigational Site | |
| Katrineholm, Sweden, 641 47 | |
| Pfizer Investigational Site | |
| Kristinehamn, Sweden, 681 29 | |
| Pfizer Investigational Site | |
| Lidkoping, Sweden, 531 85 | |
| Pfizer Investigational Site | |
| Malmo, Sweden, 205 02 | |
| Pfizer Investigational Site | |
| Munkfors, Sweden, 684 23 | |
| Pfizer Investigational Site | |
| Nassjo, Sweden, 576 81 | |
| Pfizer Investigational Site | |
| Ostersund, Sweden, 831 31 | |
| Pfizer Investigational Site | |
| Oxie, Sweden, 238 40 | |
| Pfizer Investigational Site | |
| Partille, Sweden, 43323 | |
| Pfizer Investigational Site | |
| Rattvik, Sweden, 795 21 | |
| Pfizer Investigational Site | |
| Sandviken, Sweden, 811 60 | |
| Pfizer Investigational Site | |
| Saro, Sweden, 429 13 | |
| Pfizer Investigational Site | |
| Sjuntorp, Sweden, 460 20 | |
| Pfizer Investigational Site | |
| Sollebrunn, Sweden, 466 30 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 116 32 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 112 35 | |
| Pfizer Investigational Site | |
| Sunne, Sweden, 686 22 | |
| Pfizer Investigational Site | |
| Trollhattan, Sweden, 461 59 | |
| Pfizer Investigational Site | |
| Tullinge, Sweden, 146 31 | |
| Pfizer Investigational Site | |
| Umeå, Sweden, 901 85 | |
| Pfizer Investigational Site | |
| Unknown, Sweden | |
| Pfizer Investigational Site | |
| Upplands Väsby, Sweden, 194 04 | |
| Pfizer Investigational Site | |
| Uppsala, Sweden, 751 25 | |
| Pfizer Investigational Site | |
| Vaxjo, Sweden, 352 41 | |
| Pfizer Investigational Site | |
| Visby, Sweden, 621 84 | |
| Pfizer Investigational Site | |
| Vännäs, Sweden, 911 82 | |
| Pfizer Investigational Site | |
| Västerås, Sweden, 722 11 | |
| Pfizer Investigational Site | |
| Växjö, Sweden, 350 04 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00630851 History of Changes |
| Other Study ID Numbers: | A2501017 |
| Study First Received: | February 27, 2008 |
| Last Updated: | April 22, 2011 |
| Health Authority: | Sweden: Medicinal Products Agency |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders 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 19, 2013