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

NCT02494531 | Completed

• 1 other identifier: P120134
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; PET; diagnosis; MCI; illiterate

Outcome Measures

Primary Outcomes (1)

• 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

  Within 2 months after inclusion

Secondary Outcomes (3)

• Comparison of the amount of amyloid deposits using florbetapir-18 Fluor-PET between illiterate and literate AD patients,

  Within 2 months after inclusion

• Comparison of the amyloid deposit location between the 2 groups (literate and illiterate)

  Within 2 months after inclusion

• correlation between amyloid load and metabolism dysfunction using Fluorodeoxyglucose (FDG)-PET in each groups

  Within 2 months after inclusion

Study Arms (1)

Positon Emission Tomographic (PET)-scan

OTHER

2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET

Radiation: Fluorodeoxyglucose-PET; Radiation: florbetapir F 18-PET

Interventions

Fluorodeoxyglucose-PET RADIATION

Fluorodeoxyglucose-PET performed within 2 months

Positon Emission Tomographic (PET)-scan

florbetapir F 18-PET RADIATION

florbetapir F 18-PET performed within 2 months

Positon Emission Tomographic (PET)-scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being under guardianship
• Residence in skilling nursing facility
• Pregnant or breast feeding women
• Alzheimer's disease caused by gene mutations
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Avicenne-Neurology

Bobigny, 93000, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Disease; Literacy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Communication; Behavior

Study Officials

• Catherine Belin, Dr

  ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)

  PRINCIPAL INVESTIGATOR

• AMEL OUSLIMANI, PM

  Assistance Publique - Hôpitaux de Paris, DRCD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: July 10, 2015
• Study Start: December 12, 2015
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2020
• Last Updated: January 13, 2021

Record last verified: 2020-12

Locations

FR (1)