Alzheimer's DiseaseEVATEMNCT01316562
Predictive Value of Cognitive Tests Performed for the Diagnosis of Alzheimer's Disease and Related Disorders
An observational study of Alzheimer's Disease and Impaired Cognition, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Impaired Cognition, Memory Disorders
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Jul 2012
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All subjects with memory complaint recruited during a free medical examination in Health examination centres of Lyon, Saint-Etienne and Angers, France
Who may be able to join
- Age ≥ 65 years
- Community-dwellers
- Volunteers receiving a free medical examination in Health examination centre
- Subjective memory complaint
Who cannot join
- Known dementia
- Sensory deficit compromising the cognitive evaluation
- Poor workmanship of the written or oral French language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CES Baraban
Lyon, 69456
Bruno Fantino, Professor, (+33)472513647, bruno.fantino@ces.cnamts.fr
Bruno Fantino, Professor
About this study
Official title: Valeur prédictive d'Une évaluation Cognitive standardisée en Centre d'Examens de Santé Pour le Diagnostic de la Maladie d'Alzheimer ou Des Maladies apparentées en Population générale Chez Les Plus de 65 Ans Avec Plainte mnésique
The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.
Read the detailed description
The main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.
- Conditions
- Alzheimer's Disease, Impaired Cognition, Memory Disorders
- Medical subject headings
- Alzheimer Disease, Cognition Disorders, Memory Disorders
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 |
|---|---|---|
| Group 1 | Healthy controls | |
| Group 2 | Patients with an Alzheimer's disease or related disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of episodic memory and executive psychometric tests
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Bruno Fantino, Professor, Principal investigator, CES de Baraban, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316562
- Sponsor's protocol ID
- 2009-025B
- Acronym
- EVATEM
- Status last verified
- Mar 2011
- First submitted
- 11 Mar 2011
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Bathsavanis A, Rouch I, Deville N, Beauchet O, Krolak-Salmon P, Fantino B. Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community-dwelling elderly people with memory complaints: the EVATEM study. Eur J Neurol. 2016 Mar;23(3):554-61. doi: 10.1111/ene.12888. Epub 2015 Oct 30.
PubMed 26518736Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Rouch I, Beauchet O, Krolak-Salmon P, Fantino B. Early detection of memory impairment in people over 65 years old consulting at Health Examination Centers for the French health insurance: the EVATEM protocol. BMC Geriatr. 2013 Jun 6;13:55. doi: 10.1186/1471-2318-13-55.
PubMed 23742705
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valeur prédictive d'Une évaluation Cognitive standardisée en Centre d'Examens de Santé Pour le Diagnostic de la Maladie d'Alzheimer ou Des Maladies apparentées en Population générale Chez Les Plus de 65 Ans Avec Plainte mnésique
- ClinicalTrials.gov ID
- NCT01316562
- Acronym / sponsor ID
- EVATEM / 2009-025B
- Conditions
- Alzheimer's Disease, Impaired Cognition, Memory Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 16 Mar 2011 (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.
The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.
Detailed description
The main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Healthy controls |
| Group 2 | – | –Patients with an Alzheimer's disease or related disorders |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All subjects with memory complaint recruited during a free medical examination in Health examination centres of Lyon, Saint-Etienne and Angers, France
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- Community-dwellers
- Volunteers receiving a free medical examination in Health examination centre
- Subjective memory complaint
Key exclusion criteria (3 listed)
- Known dementia
- Sensory deficit compromising the cognitive evaluation
- Poor workmanship of the written or oral French language
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
Score of episodic memory and executive psychometric tests
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 26518736Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Bathsavanis A, Rouch I, Deville N, Beauchet O, Krolak-Salmon P, Fantino B. Performance of cognitive tests, individually and combined, for the detection of cognitive disorders amongst community-dwelling elderly people with memory complaints: the EVATEM study. Eur J Neurol. 2016 Mar;23(3):554-61. doi: 10.1111/ene.12888. Epub 2015 Oct 30.
- Derived from this study: PubMed 23742705Vannier-Nitenberg C, Dauphinot V, Bongue B, Sass C, Rouch I, Beauchet O, Krolak-Salmon P, Fantino B. Early detection of memory impairment in people over 65 years old consulting at Health Examination Centers for the French health insurance: the EVATEM protocol. BMC Geriatr. 2013 Jun 6;13:55. doi: 10.1186/1471-2318-13-55.
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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.
Bruno Fantino, Professor principal investigator
CES de Baraban, Lyon
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's Disease and Impaired Cognition, run by University Hospital, Angers 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 4 inclusion and 3 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 Mar 2012. 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 Bruno Fantino, Professor ((+33)472513647, bruno.fantino@ces.cnamts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of episodic memory and executive psychometric tests (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316562, which also lists 2 linked publications.
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 Mar 2012.