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Completed

NCT Number: NCT00630851

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

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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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Fritsla, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Matching placebo tablets orally once daily for 6 months

Primary outcomes

  1. 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

  2. Change from baseline in Severe Impairment Battery (SIB) total score

    Time frame: Month 6

Secondary outcomes

  1. Change from baseline in SIB total score

    Time frame: Month 3

  2. Change from baseline in Neuropsychiatric Inventory (NPI) total score

    Time frame: Months 3 and 6

  3. Change from inclusion in Mini Mental State Examination (MMSE) total score

    Time frame: Month 6

  4. Change from baseline in Clinical Global Impression of Improvement (CGI-I) score

    Time frame: Months 3 and 6

  5. Adverse events and laboratory value changes

    Time frame: Months 3 and 6

  6. Change from baseline in modified ADCS-ADL-severe total score

    Time frame: Month 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2004
First posted
Mar 7, 2008
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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