A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

Condition(s) targeted: Alzheimer Disease

Intervention: Donepezil (Aricept) (Drug); Placebo (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

The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

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

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

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

Pfizer Investigational Site, Kalix 952 82, Sweden

Pfizer Investigational Site, Vännäs 911 82, Sweden

Pfizer Investigational Site, Umeå 901 85, Sweden

Pfizer Investigational Site, Unknown, Sweden

Pfizer Investigational Site, Hedemora 776 28, Sweden

Pfizer Investigational Site, Uppsala 751 25, Sweden

Pfizer Investigational Site, Västerås 722 11, Sweden

Pfizer Investigational Site, Upplands Väsby 194 04, Sweden

Pfizer Investigational Site, Gustavsberg 134 30, Sweden

Pfizer Investigational Site, Stockholm 112 35, Sweden

Pfizer Investigational Site, Karlstad 656 37, Sweden

Pfizer Investigational Site, Aneby 578 21, Sweden

Pfizer Investigational Site, Jönköping 553 16, Sweden

Pfizer Investigational Site, Växjö 350 04, Sweden

Pfizer Investigational Site, Helsingborg 254 43, Sweden

Pfizer Investigational Site, AVESTA 774 82, Sweden

Pfizer Investigational Site, BORLANGE 781 27, Sweden

Pfizer Investigational Site, DEGERFORS 693 22, Sweden

Pfizer Investigational Site, ESKILSTUNA 632 23, Sweden

Pfizer Investigational Site, ESKILSTUNA 631 88, Sweden

Pfizer Investigational Site, FRITSLA 510 29, Sweden

Pfizer Investigational Site, GISLAVED 332 30, Sweden

Pfizer Investigational Site, GOTEBORG 412 75, Sweden

Pfizer Investigational Site, MUNKFORS 684 23, Sweden

Pfizer Investigational Site, NASSJO 576 81, Sweden

Pfizer Investigational Site, INGELSTAD 360 44, Sweden

Pfizer Investigational Site, PARTILLE 43323, Sweden

Pfizer Investigational Site, RATTVIK 795 21, Sweden

Pfizer Investigational Site, VISBY 621 84, Sweden

Pfizer Investigational Site, VAXJO 352 41, Sweden

Pfizer Investigational Site, AKERSBERGA 184 33 AKERSBERGA, Sweden

Pfizer Investigational Site, ARSTA 120 54, Sweden

Pfizer Investigational Site, SUNNE 686 22, Sweden

Pfizer Investigational Site, OSTERSUND 831 31, Sweden

Pfizer Investigational Site, MALMO 205 02, Sweden

Pfizer Investigational Site, KRISTINEHAMN 681 29, Sweden

Pfizer Investigational Site, TROLLHATTAN 461 59, Sweden

Pfizer Investigational Site, SJUNTORP 460 20, Sweden

Pfizer Investigational Site, 135 21 TYRESO, Sweden

Pfizer Investigational Site, Oxie 238 40, Sweden

Pfizer Investigational Site, Stockholm 116 32, Sweden

Pfizer Investigational Site, Saro 429 13, Sweden

Pfizer Investigational Site, LIDKOPING 531 85, Sweden

Pfizer Investigational Site, GULLSPANG 547 31, Sweden

Pfizer Investigational Site, Katrineholm 641 47, Sweden

Pfizer Investigational Site, Sandviken 811 60, Sweden

Pfizer Investigational Site, Bengtsfors 666 30, Sweden

Pfizer Investigational Site, BERGSJO 820 70, Sweden

Pfizer Investigational Site, Boden 931 64, Sweden

Pfizer Investigational Site, Alunda 747 30, Sweden

Pfizer Investigational Site, Sollebrunn 466 30, Sweden

Pfizer Investigational Site, Tullinge 146 31, Sweden

Pfizer Investigational Site, VARNAMO, 331 85, Sweden

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

Link to ClinicalStudyResults.org Posting

Starting date: October 2002
Ending date: October 2004
Last updated: April 23, 2008