Alzheimer DiseaseNCT01570322
Determinants of Quality of Life Related to Health in Alzheimer Disease
An observational study of Alzheimer Disease, run by CHU de Reims at 1 site in France.
Trial summary
Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including: The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL), The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL), The influence of… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Alzheimer Disease
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: * Patients with Alzheimer disease (DSM IV - Diagnostic and Statistical Manual of Mental Disorders - and NINCDS/ADRDA - National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association) * Patients with MMSE (Mini Mental State Examination) > or = 10
Who may be able to join
- Patients with Alzheimer disease (DSM IV and NINCDS-ADRDA)
- Patients with MMSE (Mini Mental State Examination) > or = 10
- Out patients
Who cannot join
- Severe sensory disturbances,
- Non French speaking
Trial locations and contacts
1 site in 1 country.
Jean-Luc NOVELLA, MD PhD contact
France1 site, 1 recruiting
- Recruiting
CHU de REIMS
Reims, France, 51092
Jean-Luc NOVELLA, MD PhD, jlnovella@chu-reims.fr
About this study
Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including:
- The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL),
- The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),
- The influence of formal and informal help mobilized,
- The influence of interactions "patient - caregiver" on Health-Related Quality of Life (HRQL),
- The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)
- Conditions
- Alzheimer Disease
- Keywords
- Dementia - Alzheimer - Quality of life
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life (HRQOL) Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570322
- Sponsor's protocol ID
- PN09004
- Status last verified
- Jun 2016
- First submitted
- 2 Apr 2012
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Quality of Life Related to Health in Alzheimer Disease
- ClinicalTrials.gov ID
- NCT01570322
- Acronym / sponsor ID
- PN09004
- Conditions
- Alzheimer Disease
- Keywords
- Dementia - Alzheimer - Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- First posted
- 4 Apr 2012 (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.
Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including:
- The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL),
- The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),
- The influence of formal and informal help mobilized,
- The influence of interactions "patient - caregiver" on Health-Related Quality of Life (HRQL),
- The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- * Patients with Alzheimer disease (DSM IV - Diagnostic and Statistical Manual of Mental Disorders - and NINCDS/ADRDA - National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association) * Patients with MMSE (Mini Mental State Examination) > or = 10
Key inclusion criteria (3 listed)
- Patients with Alzheimer disease (DSM IV and NINCDS-ADRDA)
- Patients with MMSE (Mini Mental State Examination) > or = 10
- Out patients
Key exclusion criteria (2 listed)
- Severe sensory disturbances,
- Non French speaking
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
Health-Related Quality of Life (HRQOL) Assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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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.
Jean-Luc NOVELLA, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by CHU de Reims at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc NOVELLA, MD PhD (jlnovella@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQOL) Assessment. 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 9 Jun 2016.