Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging (AVILL)
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|ClinicalTrials.gov Identifier: NCT02494531|
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Radiation: Fluorodeoxyglucose-PET Radiation: florbetapir F 18-PET||Not Applicable|
Illiterate, with a higher rate in the elder and in multi-cultural population reaching, then, 20%. Most of these patients are not usually included in research studies.
Thus, AVILL would specifically focus on lower educated and illiterate patients and on use of PET imaging for early diagnosis. This study would take advantage of the collaboration with the recently launched Memento cohort.
- The diagnosis of AD at the early stages of the disease appears to be crucial. MCI is now considered as the 1st clinical stage of the disease, after a long pre-clinical period.
- Cognitive reserve modulates the relationship between cerebral lesions and their clinical manifestations by limiting the negative impact of cerebral lesion on cognition. Education is a commonly-used proxy of cognitive reserve. Education interacts with AD pathology such that a greater pathological burden is required to show an effect on cognition among subjects with more education. Lower education and illiteracy are thus considered as risk factor of developing AD
Diagnosing MCI and AD in lower educated and illiterate patients is a real challenge because of:
- -difficulties in cognitive evaluation which mostly relies on educational background and reading abilities,
- -poor adaptation of neuropsychological tests,
- -lack of clinical and imaging data concerning these patients, who are often excluded from studies, and poor knowledge of the evolution of the disease from the earlier signs (MCI) to dementia.
- Quantification of amyloid deposit by PET imaging could therefore be useful for the diagnosis of AD in illiterate patients.
- non educated patient amyloid load could differ from educated patient amyloid load at the same stage of cognitive impairment
- PET amyloid imaging using florbetapir F 18 could detect non educated patients with AD risk at early stage and could help clinical evaluation which is particularly difficult in this population.
- uptake level of florbetapir F 18 could be different in MCI and AD non educated patients compared to educated patients which are the basis of the objectives.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Positon Emission Tomographic (PET)-scan
2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET
Fluorodeoxyglucose-PET performed within 2 months
Radiation: florbetapir F 18-PET
florbetapir F 18-PET performed within 2 months
- Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate MCI patients [ Time Frame: Within 2 months after inclusion ]Comparison between the 2 groups (educated and non -educated) of florbetapir-18 Fluor Standardized Uptake Values (SUV) ratios (max and mean of SUVr) in MCI patients
- Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate AD patients, [ Time Frame: Within 2 months after inclusion ]Comparison of florbetapir-18 Fluor SUV (Standardized Uptake Values) ratios (max and mean of SUVr) in the different groups as defined above
- Comparison of the amyloid deposit location between the 2 groups (literate and illiterate) [ Time Frame: Within 2 months after inclusion ]Group comparison of qualitative topography of amyloid burden
- correlation between amyloid load and metabolism dysfunction using Fluorodeoxyglucose (FDG)-PET in each groups [ Time Frame: Within 2 months after inclusion ]Group comparison of topography of amyloid deposit and FDG metabolism
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 ClinicalTrials.gov identifier (NCT number): NCT02494531
|Contact: Catherine Belin, Dr||01 48 95 54 firstname.lastname@example.org|
|Contact: Nacira DARGHAL, PM||01 48 95 74 email@example.com|
|Bobigny, France, 93000|
|Contact: Catherine BELIN, DR 0033148955401 firstname.lastname@example.org|
|Principal Investigator:||Catherine Belin, Dr||ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)|
|Study Director:||AMEL OUSLIMANI, PM||Assistance Publique - Hôpitaux de Paris, DRCD|