- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02494531
Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging (AVILL)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bobigny, France, 93000
- Hospital Avicenne-Neurology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Positon Emission Tomographic (PET)-scan
2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET
|
Fluorodeoxyglucose-PET performed within 2 months
florbetapir F 18-PET performed within 2 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 2 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 2 months after inclusion
|
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
|
Within 2 months after inclusion
|
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
|
Within 2 months after inclusion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine Belin, Dr, ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)
- Study Director: AMEL OUSLIMANI, PM, Assistance Publique - Hôpitaux de Paris, DRCD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P120134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on Fluorodeoxyglucose-PET
-
Washington University School of MedicineNational Cancer Institute (NCI)Completed
-
University of Wisconsin, MadisonNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruiting
-
Washington University School of MedicineNational Cancer Institute (NCI)Recruiting
-
Yale UniversityCompletedSarcoidosisUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingCervical Cancer | Endometrial CancerUnited States
-
University of MichiganCompletedMyocardial Infarction | Ischemic Heart DiseaseUnited States
-
Zahi FayadMassachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI) and other collaboratorsCompletedPTSD | Healthy | TraumaUnited States
-
Ottawa Heart Institute Research CorporationThe Ottawa HospitalTerminatedStroke | Carotid Artery Stenosis | TIACanada
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
British Columbia Cancer AgencyApproved for marketing