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Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging

Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494531
Acronym
AVILL
Enrollment
45
Registered
2015-07-10
Start date
2015-12-12
Completion date
2020-05-06
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease, PET, diagnosis, MCI, illiterate

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: 1. 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. 2. 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 3. Diagnosing MCI and AD in lower educated and illiterate patients is a real challenge because of: 1. -difficulties in cognitive evaluation which mostly relies on educational background and reading abilities, 2. -poor adaptation of neuropsychological tests, 3. -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. 4. 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.

Interventions

RADIATIONFluorodeoxyglucose-PET

Fluorodeoxyglucose-PET performed within 2 months

RADIATIONflorbetapir F 18-PET

florbetapir F 18-PET performed within 2 months

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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 2. 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 3. 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate MCI patientsWithin 2 months after inclusionComparison 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

MeasureTime frameDescription
Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate AD patients,Within 2 months after inclusionComparison 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)Within 2 months after inclusionGroup comparison of qualitative topography of amyloid burden
correlation between amyloid load and metabolism dysfunction using Fluorodeoxyglucose (FDG)-PET in each groupsWithin 2 months after inclusionGroup comparison of topography of amyloid deposit and FDG metabolism

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026