Observational Study on Costs and Caregiver Burden in Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	AstraZeneca i3 Innovus
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00698165

Purpose

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

Condition
Alzheimer's Disease

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Cross-Sectional
Official Title:	Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Collected one time only ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Resource Utilization in Dementia (RUD) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
Short Form - 12 domains instrument (SF-12) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
World Health Organization Quality of Life instrument (WHO-QoL) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
Zarit Caregiver Burden Interview (ZBI) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]
15 domains Quality of Life Index instrument (15D) [ Time Frame: collected one time only ] [ Designated as safety issue: No ]

Estimated Enrollment:	2400
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
Patients 1200 adults with mild to severe Alzheimer's disease
Caregivers 1200 informal caregivers

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adults with Alzheimer's Disease and their informal caregivers are recruited from both outpatient settings and long-term residential care settings

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698165

Show 82 Study Locations

Sponsors and Collaborators

AstraZeneca

i3 Innovus

Investigators

Study Director:

Linus Jönsson

i3 Innovus

More Information

Responsible Party:	AstraZeneca R&D ( Hans-Göran Hårdemark, Medical Science Director )
Study ID Numbers:	EHE 1100
Study First Received:	June 16, 2008
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00698165
Health Authority:	Spain: Comité Ético de Investigación Clínica; Sweden: Regional Ethical Review Board; United Kingdom: National Health Service

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009