Clinical trial NCT00630851: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 249
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Month 6
measure: Change from baseline in Severe Impairment Battery (SIB) total score
timeFrame: Month 6
Secondary outcomes:
measure: Change from baseline in SIB total score
timeFrame: Month 3
measure: Change from baseline in Neuropsychiatric Inventory (NPI) total score
timeFrame: Months 3 and 6
measure: Change from inclusion in Mini Mental State Examination (MMSE) total score
timeFrame: Month 6
measure: Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
timeFrame: Months 3 and 6
measure: Adverse events and laboratory value changes
timeFrame: Months 3 and 6
measure: Change from baseline in modified ADCS-ADL-severe total score
timeFrame: Month 3
Other outcomes:
Locations:
city: Akersberga
country: Sweden
facility: Pfizer Investigational Site
city: Alunda
country: Sweden
facility: Pfizer Investigational Site
city: Aneby
country: Sweden
facility: Pfizer Investigational Site
city: Arsta
country: Sweden
facility: Pfizer Investigational Site
city: Avesta
country: Sweden
facility: Pfizer Investigational Site
city: Bengtsfors
country: Sweden
facility: Pfizer Investigational Site
city: Bergsjo
country: Sweden
facility: Pfizer Investigational Site
city: Boden
country: Sweden
facility: Pfizer Investigational Site
city: Borlange
country: Sweden
facility: Pfizer Investigational Site
city: Degerfors
country: Sweden
facility: Pfizer Investigational Site
city: Eskilstuna
country: Sweden
facility: Pfizer Investigational Site
city: Eskilstuna
country: Sweden
facility: Pfizer Investigational Site
city: Fritsla
country: Sweden
facility: Pfizer Investigational Site
city: Gislaved
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Gullspang
country: Sweden
facility: Pfizer Investigational Site
city: Gustavsberg
country: Sweden
facility: Pfizer Investigational Site
city: Hedemora
country: Sweden
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Ingelstad
country: Sweden
facility: Pfizer Investigational Site
city: Jönköping
country: Sweden
facility: Pfizer Investigational Site
city: Kalix
country: Sweden
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Katrineholm
country: Sweden
facility: Pfizer Investigational Site
city: Kristinehamn
country: Sweden
facility: Pfizer Investigational Site
city: Lidkoping
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Munkfors
country: Sweden
facility: Pfizer Investigational Site
city: Nassjo
country: Sweden
facility: Pfizer Investigational Site
city: Ostersund
country: Sweden
facility: Pfizer Investigational Site
city: Oxie
country: Sweden
facility: Pfizer Investigational Site
city: Partille
country: Sweden
facility: Pfizer Investigational Site
city: Rattvik
country: Sweden
facility: Pfizer Investigational Site
city: Sandviken
country: Sweden
facility: Pfizer Investigational Site
city: Saro
country: Sweden
facility: Pfizer Investigational Site
city: Sjuntorp
country: Sweden
facility: Pfizer Investigational Site
city: Sollebrunn
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Sunne
country: Sweden
facility: Pfizer Investigational Site
city: Trollhattan
country: Sweden
facility: Pfizer Investigational Site
city: Tullinge
country: Sweden
facility: Pfizer Investigational Site
city: Tyreso
country: Sweden
facility: Pfizer Investigational Site
city: Umeå
country: Sweden
facility: Pfizer Investigational Site
city: Upplands Väsby
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Varnamo
country: Sweden
facility: Pfizer Investigational Site
city: Vaxjo
country: Sweden
facility: Pfizer Investigational Site
city: Visby
country: Sweden
facility: Pfizer Investigational Site
city: Vännäs
country: Sweden
facility: Pfizer Investigational Site
city: Västerås
country: Sweden
facility: Pfizer Investigational Site
city: Växjö
country: Sweden
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: