Alzheimer's Disease Clinical Trial
Official title:
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
Objective of study is to assess the costs of care, objective and subjective caregiver burden and quality of life in relation to disease severity measured by cognitive function, ADL capabilities and presence of behavioral disturbances in Alzheimer's disease
| Status | Completed |
| Enrollment | 2400 |
| Est. completion date | January 2009 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of possible or probable Alzheimer's disease, with or without vascular elements - The primary caregiver can be identified - The patient and his/her primary caregiver are both willing and able to participate in the study Exclusion Criteria: - Patient or caregiver affected by alcohol or narcotics to the extent that it interferes with the completion of the study - Patient or caregiver does not understand English - Patient and/ or caregiver is the physician or physician's staff - Patient and/ or caregiver is a family member of the physician or physician's staff |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Spain | Research Site | Alicante | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Burgos | |
| Spain | Research Site | Cruces | Barakaldo |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Seville | |
| Sweden | Research Site | Bergsjo | |
| Sweden | Research Site | Bromma | |
| Sweden | Research Site | Jonkoping | |
| Sweden | Research Site | Karlstad | |
| Sweden | Research Site | Kristianstad | |
| Sweden | Research Site | Lomma | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Malmo | |
| Sweden | Research Site | Ornskoldsvik | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Umea | |
| Sweden | Research Site | Uppsala | |
| Sweden | Research Site | Varberg | |
| United Kingdom | Research Site | Barnet | Hertfordshire |
| United Kingdom | Research Site | Brighton | |
| United Kingdom | Research Site | Chester | |
| United Kingdom | Research Site | Coney Hill | Gloucester |
| United Kingdom | Research Site | Eastbourne | East Sussex |
| United Kingdom | Research Site | Hove | |
| United Kingdom | Research Site | Ipswich | |
| United Kingdom | Research Site | Norwich | |
| United Kingdom | Research Site | Overton | Basingstoke |
| United Kingdom | Research Site | Oxford | |
| United Kingdom | Research Site | Romsey | |
| United Kingdom | Research Site | Salisbury | |
| United Kingdom | Research Site | Stanmore | |
| United Kingdom | Research Site | Uckfield | |
| United Kingdom | Research Site | Wood Green | London |
| United States | Research Site | Albany | New York |
| United States | Research Site | Asheboro | North Carolina |
| United States | Research Site | Atlantis | Florida |
| United States | Research Site | Beaufort | South Carolina |
| United States | Research Site | Belleville | Illinois |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Brentwood | California |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Canton | Georgia |
| United States | Research Site | Centerville | Ohio |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Dunwoody | Georgia |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | Eaton Rapids | Michigan |
| United States | Research Site | Eatontown | New Jersey |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Fresno | California |
| United States | Research Site | Ft Wayne | Indiana |
| United States | Research Site | Gig Harbor | Washington |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | LaHabra | California |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Northport | Alabama |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pittsfield | Massachusetts |
| United States | Research Site | Port Arthur | Texas |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Prince Frederick | Maryland |
| United States | Research Site | Richland | Washington |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Snellville | Georgia |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Summerville | South Carolina |
| United States | Research Site | Syracuse | New York |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Titusville | Florida |
| United States | Research Site | Tyler | Texas |
| United States | Research Site | Venice | Florida |
| United States | Research Site | Wetherfield | Connecticut |
| United States | Research Site | Winston Salem | North Carolina |
| United States | Research Site | Witchita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | i3 Innovus |
United States, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) | Collected one time only | No | |
| Secondary | Resource Utilization in Dementia (RUD) | collected one time only | No | |
| Secondary | Short Form - 12 domains instrument (SF-12) | collected one time only | No | |
| Secondary | World Health Organization Quality of Life instrument (WHO-QoL) | collected one time only | No | |
| Secondary | Zarit Caregiver Burden Interview (ZBI) | collected one time only | No | |
| Secondary | 15 domains Quality of Life Index instrument (15D) | collected one time only | No |
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