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The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil (Aricept) | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Fritsla | Sweden | 510 29 | Sweden | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | Matching placebo tablets orally once daily for 6 months |
|
| 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 |
| Change from baseline in modified ADCS-ADL-severe total score | Month 3 |
| 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 | Malmö | 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 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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