Alzheimer's DiseaseNCT00698165
Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
An observational study of Alzheimer's Disease, run by AstraZeneca at 82 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 2,400 participants
- Where
- 82 sitesin 4 countries
- Study dates
- Jun 2007to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with Alzheimer's Disease and their informal caregivers are recruited from both outpatient settings and long-term residential care settings
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
82 sites in 4 countries.
82 sites in 4 countries
United States48 sites
Research Site
Albany, New York
Research Site
Asheboro, North Carolina
Research Site
Atlantis, Florida
Research Site
Beaufort, South Carolina
Research Site
Belleville, Illinois
Research Site
Bethesda, Maryland
Research Site
Brentwood, California
Research Site
Brooklyn, New York
Research Site
Canton, Georgia
Research Site
Canton, Ohio
Research Site
Centerville, Ohio
Research Site
Charlotte, North Carolina
Research Site
Columbus, Georgia
Research Site
Decatur, Georgia
Research Site
Denver, Colorado
Research Site
Dunwoody, Georgia
Research Site
East Providence, Rhode Island
Research Site
Eaton Rapids, Michigan
Research Site
Eatontown, New Jersey
Research Site
Fort Myers, Florida
Research Site
Fort Wayne, Indiana
Research Site
Fresno, California
Research Site
Gig Harbor, Washington
Research Site
Hickory, North Carolina
Research Site
La Habra, California
Research Site
Long Beach, California
Research Site
Miami, Florida
Research Site
Norfolk, Virginia
Research Site
Northport, Alabama
Research Site
Oklahoma City, Oklahoma
Research Site
Phoenix, Arizona
Research Site
Pittsfield, Massachusetts
Research Site
Port Arthur, Texas
Research Site
Port Charlotte, Florida
Research Site
Prince Frederick, Maryland
Research Site
Richland, Washington
Research Site
Shreveport, Louisiana
Research Site
Snellville, Georgia
Research Site
St Louis, Missouri
Research Site
Summerville, South Carolina
Research Site
Syracuse, New York
Research Site
Tampa, Florida
Research Site
Titusville, Florida
Research Site
Tyler, Texas
Research Site
Venice, Florida
Research Site
Wetherfield, Connecticut
Research Site
Winston-Salem, North Carolina
Research Site
Witchita Falls, Texas
United Kingdom15 sites
Research Site
Barnet, Hertfordshire
Research Site
Brighton
Research Site
Chester
Research Site
Coney Hill, Gloucester
Research Site
Eastbourne, East Sussex
Research Site
Hove
Research Site
Ipswich
Research Site
Norwich
Research Site
Overton, Basingstoke
Research Site
Oxford
Research Site
Romsey
Research Site
Salisbury
Research Site
Stanmore
Research Site
Uckfield
Research Site
Wood Green, London
Sweden13 sites
Research Site
Bergsjö
Research Site
Bromma
Research Site
Jönköping
Research Site
Karlstad
Research Site
Kristianstad
Research Site
Lomma
Research Site
Lund
Research Site
Malmö
Research Site
Örnsköldsvik
Research Site
Stockholm
Research Site
Umeå
Research Site
Uppsala
Research Site
Varberg
Spain6 sites
Research Site
Alicante
Research Site
Barcelona
Research Site
Burgos
Research Site
Cruces, Barakaldo
Research Site
Madrid
Research Site
Seville
About this study
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
- Conditions
- Alzheimer's Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 1200 adults with mild to severe Alzheimer's disease | |
| Caregivers | 1200 informal caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q)
Measured: Collected one time only
Secondary outcomes (5)
Resource Utilization in Dementia (RUD)
Measured: collected one time only
Short Form - 12 domains instrument (SF-12)
Measured: collected one time only
World Health Organization Quality of Life instrument (WHO-QoL)
Measured: collected one time only
Zarit Caregiver Burden Interview (ZBI)
Measured: collected one time only
15 domains Quality of Life Index instrument (15D)
Measured: collected one time only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Innovus
- Investigators
- Linus Jönsson, Study director, i3 Innovus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698165
- Sponsor's protocol ID
- EHE 1100
- Status last verified
- Feb 2009
- First submitted
- 16 Jun 2008
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Costs and Caregiver Burden in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00698165
- Acronym / sponsor ID
- EHE 1100
- Conditions
- Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- i3 Innovus
- Study start
- Jun 2007
- Study completion
- Jan 2009 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –1200 adults with mild to severe Alzheimer's disease |
| Caregivers | – | –1200 informal caregivers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with Alzheimer's Disease and their informal caregivers are recruited from both outpatient settings and long-term residential care settings
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: Collected one time only
5 secondary outcomes
Resource Utilization in Dementia (RUD)
Time frame: collected one time only
Short Form - 12 domains instrument (SF-12)
Time frame: collected one time only
World Health Organization Quality of Life instrument (WHO-QoL)
Time frame: collected one time only
Zarit Caregiver Burden Interview (ZBI)
Time frame: collected one time only
15 domains Quality of Life Index instrument (15D)
Time frame: collected one time only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linus Jönsson study director
i3 Innovus
82 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by AstraZeneca at 82 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, United Kingdom, Sweden, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE), Disability Assessment for Dementia Scale (DAD), Neuropsychiatric Inventory Questionnaire (NPI-Q) (time frame: Collected one time only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2009.