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OpenTrials
Completed

NCT Number: NCT00698165

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Cruces, Barakaldo, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q)

    Time frame: Collected one time only

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • i3 Innovus

Registry information

Important dates

Study start
2007
Study completion
2009
First posted
Jun 17, 2008
Registry last updated
Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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