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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00698165
Other study ID # EHE 1100
Secondary ID
Status Completed
Phase N/A
First received June 16, 2008
Last updated February 19, 2009
Start date June 2007
Est. completion date January 2009

Study information

Verified date February 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación ClínicaSweden: Regional Ethical Review BoardUnited Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca i3 Innovus

Countries where clinical trial is conducted

United States,  Spain,  Sweden,  United Kingdom, 

Outcome

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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