Alzheimer Disease Clinical Trial
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
| Verified date | March 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medicinal Products Agency |
| Study type | Interventional |
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
| Status | Completed |
| Enrollment | 249 |
| Est. completion date | October 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Pfizer Investigational Site | Akersberga | |
| Sweden | Pfizer Investigational Site | Alunda | |
| Sweden | Pfizer Investigational Site | Aneby | |
| Sweden | Pfizer Investigational Site | Arsta | |
| Sweden | Pfizer Investigational Site | Avesta | |
| Sweden | Pfizer Investigational Site | Bengtsfors | |
| Sweden | Pfizer Investigational Site | Bergsjo | |
| Sweden | Pfizer Investigational Site | Boden | |
| Sweden | Pfizer Investigational Site | Borlange | |
| Sweden | Pfizer Investigational Site | Degerfors | |
| Sweden | Pfizer Investigational Site | Eskilstuna | |
| Sweden | Pfizer Investigational Site | Eskilstuna | |
| Sweden | Pfizer Investigational Site | Fritsla | |
| Sweden | Pfizer Investigational Site | Gislaved | |
| Sweden | Pfizer Investigational Site | Goteborg | |
| Sweden | Pfizer Investigational Site | Gullspang | |
| Sweden | Pfizer Investigational Site | Gustavsberg | |
| Sweden | Pfizer Investigational Site | Hedemora | |
| Sweden | Pfizer Investigational Site | Helsingborg | |
| Sweden | Pfizer Investigational Site | Ingelstad | |
| Sweden | Pfizer Investigational Site | Jönköping | |
| Sweden | Pfizer Investigational Site | Kalix | |
| Sweden | Pfizer Investigational Site | Karlstad | |
| Sweden | Pfizer Investigational Site | Katrineholm | |
| Sweden | Pfizer Investigational Site | Kristinehamn | |
| Sweden | Pfizer Investigational Site | Lidkoping | |
| Sweden | Pfizer Investigational Site | Malmo | |
| Sweden | Pfizer Investigational Site | Munkfors | |
| Sweden | Pfizer Investigational Site | Nassjo | |
| Sweden | Pfizer Investigational Site | Ostersund | |
| Sweden | Pfizer Investigational Site | Oxie | |
| Sweden | Pfizer Investigational Site | Partille | |
| Sweden | Pfizer Investigational Site | Rattvik | |
| Sweden | Pfizer Investigational Site | Sandviken | |
| Sweden | Pfizer Investigational Site | Saro | |
| Sweden | Pfizer Investigational Site | Sjuntorp | |
| Sweden | Pfizer Investigational Site | Sollebrunn | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| Sweden | Pfizer Investigational Site | Sunne | |
| Sweden | Pfizer Investigational Site | Trollhattan | |
| Sweden | Pfizer Investigational Site | Tullinge | |
| Sweden | Pfizer Investigational Site | Tyreso | |
| Sweden | Pfizer Investigational Site | Umeå | |
| Sweden | Pfizer Investigational Site | Unknown | |
| Sweden | Pfizer Investigational Site | Upplands Väsby | |
| Sweden | Pfizer Investigational Site | Uppsala | |
| Sweden | Pfizer Investigational Site | Vännäs | |
| Sweden | Pfizer Investigational Site | Varnamo | |
| Sweden | Pfizer Investigational Site | Västerås | |
| Sweden | Pfizer Investigational Site | Vaxjo | |
| Sweden | Pfizer Investigational Site | Växjö | |
| Sweden | Pfizer Investigational Site | Visby |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Primary | Change from baseline in Severe Impairment Battery (SIB) total score | Month 6 | No | |
| Secondary | Change from baseline in SIB total score | Month 3 | No | |
| Secondary | Change from baseline in Neuropsychiatric Inventory (NPI) total score | Months 3 and 6 | No | |
| Secondary | Change from inclusion in Mini Mental State Examination (MMSE) total score | Month 6 | No | |
| Secondary | Change from baseline in Clinical Global Impression of Improvement (CGI-I) score | Months 3 and 6 | No | |
| Secondary | Adverse events and laboratory value changes | Months 3 and 6 | Yes | |
| Secondary | Change from baseline in modified ADCS-ADL-severe total score | Month 3 | No |
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