Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging (AVILL)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fluorodeoxyglucose-PET
florbetapir F 18-PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer Disease, PET, diagnosis, MCI, illiterate
Eligibility Criteria
Inclusion Criteria:
For all patients enrolled in the study:
- Aged 18 years and above
- Visual and auditory acuity adequate for neuropsychological testing
- Having signed an informed consent
- Being affiliated to health insurance
For MCI patients:
For this group, the criteria are the same as those of Memento but with specially designed neuropsychological tests for illiterate/low educated patients.
- Performing worse than one standard deviation to the mean (compared to age and educational norms) in one or more cognitive domains (neuropsychological tests battery exploring memory, language, praxis, vision, executive functions); this deviation is required to be documented by tests performed less than 6 months age
- Clinical dementia Rating scale < or = 0.5
For AD patients
- Fulfilling DSM IV criteria of AD
- Clinical Dementia Rating scale > 0.5 Patients are defined as "illiterate" having 5 or less years of schooling, and "literate" when having more than 5 years
Exclusion Criteria:
- Being under guardianship
- Residence in skilling nursing facility
- Pregnant or breast feeding women
- Alzheimer's disease caused by gene mutations
- Brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body) or refusing MRI
- Neurological disease such as: treated epilepsy, treated Parkinson's disease, Huntington disease, brain tumour, subdural haematoma, progressive supranuclear palsy, history of head trauma followed by persistent neurological deficits, history of stroke
- Schizophrenia or other psychiatric history (DSM-IV criteria)
Sites / Locations
- Hospital Avicenne-Neurology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Positon Emission Tomographic (PET)-scan
Arm Description
2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET
Outcomes
Primary Outcome Measures
Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate MCI patients
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
Secondary Outcome Measures
Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate AD patients,
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)
Group comparison of qualitative topography of amyloid burden
correlation between amyloid load and metabolism dysfunction using Fluorodeoxyglucose (FDG)-PET in each groups
Group comparison of topography of amyloid deposit and FDG metabolism
Full Information
NCT ID
NCT02494531
First Posted
May 4, 2015
Last Updated
January 12, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02494531
Brief Title
Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging
Acronym
AVILL
Official Title
Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2015 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
May 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
5. Study Description
Brief Summary
The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose - and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral metabolism dysfunction in literate versus illiterate MCI and AD patients.
Detailed Description
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.
RATIONALE:
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.
GENERAL OBJECTIVES:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease, PET, diagnosis, MCI, illiterate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Positon Emission Tomographic (PET)-scan
Arm Type
Other
Arm Description
2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET
Intervention Type
Radiation
Intervention Name(s)
Fluorodeoxyglucose-PET
Intervention Description
Fluorodeoxyglucose-PET performed within 2 months
Intervention Type
Radiation
Intervention Name(s)
florbetapir F 18-PET
Intervention Description
florbetapir F 18-PET performed within 2 months
Primary Outcome Measure Information:
Title
Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate MCI patients
Description
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
Time Frame
Within 2 months after inclusion
Secondary Outcome Measure Information:
Title
Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate AD patients,
Description
Comparison of florbetapir-18 Fluor SUV (Standardized Uptake Values) ratios (max and mean of SUVr) in the different groups as defined above
Time Frame
Within 2 months after inclusion
Title
Comparison of the amyloid deposit location between the 2 groups (literate and illiterate)
Description
Group comparison of qualitative topography of amyloid burden
Time Frame
Within 2 months after inclusion
Title
correlation between amyloid load and metabolism dysfunction using Fluorodeoxyglucose (FDG)-PET in each groups
Description
Group comparison of topography of amyloid deposit and FDG metabolism
Time Frame
Within 2 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For all patients enrolled in the study:
Aged 18 years and above
Visual and auditory acuity adequate for neuropsychological testing
Having signed an informed consent
Being affiliated to health insurance
For MCI patients:
For this group, the criteria are the same as those of Memento but with specially designed neuropsychological tests for illiterate/low educated patients.
Performing worse than one standard deviation to the mean (compared to age and educational norms) in one or more cognitive domains (neuropsychological tests battery exploring memory, language, praxis, vision, executive functions); this deviation is required to be documented by tests performed less than 6 months age
Clinical dementia Rating scale < or = 0.5
For AD patients
Fulfilling DSM IV criteria of AD
Clinical Dementia Rating scale > 0.5 Patients are defined as "illiterate" having 5 or less years of schooling, and "literate" when having more than 5 years
Exclusion Criteria:
Being under guardianship
Residence in skilling nursing facility
Pregnant or breast feeding women
Alzheimer's disease caused by gene mutations
Brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body) or refusing MRI
Neurological disease such as: treated epilepsy, treated Parkinson's disease, Huntington disease, brain tumour, subdural haematoma, progressive supranuclear palsy, history of head trauma followed by persistent neurological deficits, history of stroke
Schizophrenia or other psychiatric history (DSM-IV criteria)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Belin, Dr
Organizational Affiliation
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AMEL OUSLIMANI, PM
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris, DRCD
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Avicenne-Neurology
City
Bobigny
ZIP/Postal Code
93000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging
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