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Observational Study on Costs and Caregiver Burden in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00698165
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : February 20, 2009
i3 Innovus
Information provided by:

Brief 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

Condition or disease
Alzheimer's Disease

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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
Study Start Date : June 2007
Actual Study Completion Date : January 2009

1200 adults with mild to severe Alzheimer's disease
1200 informal caregivers

Primary Outcome Measures :
  1. Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Collected one time only ]

Secondary Outcome Measures :
  1. Resource Utilization in Dementia (RUD) [ Time Frame: collected one time only ]
  2. Short Form - 12 domains instrument (SF-12) [ Time Frame: collected one time only ]
  3. World Health Organization Quality of Life instrument (WHO-QoL) [ Time Frame: collected one time only ]
  4. Zarit Caregiver Burden Interview (ZBI) [ Time Frame: collected one time only ]
  5. 15 domains Quality of Life Index instrument (15D) [ Time Frame: collected one time only ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00698165

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Sponsors and Collaborators
i3 Innovus
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Study Director: Linus Jönsson i3 Innovus
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Responsible Party: Hans-Göran Hårdemark, Medical Science Director, AstraZeneca R&D Identifier: NCT00698165    
Other Study ID Numbers: EHE 1100
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders