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Trial record 26 of 460 for:    Recruiting, Not yet recruiting, Available Studies | "Alzheimer Disease"

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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Radiation: Fluorodeoxyglucose-PET Radiation: florbetapir F 18-PET Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Positon Emission Tomographic (PET)-scan
2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET
Radiation: Fluorodeoxyglucose-PET
Fluorodeoxyglucose-PET performed within 2 months

Radiation: florbetapir F 18-PET
florbetapir F 18-PET performed within 2 months




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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)

Information from the National Library of Medicine

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


Contacts
Contact: Catherine Belin, Dr 01 48 95 54 01 catherine.belin@avc.aphp.fr
Contact: Nacira DARGHAL, PM 01 48 95 74 73 nacira.darghal@avc.aphp.fr

Locations
France
Hospital Avicenne-Neurology Recruiting
Bobigny, France, 93000
Contact: Catherine BELIN, DR    0033148955401    catherine.belin@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Catherine Belin, Dr ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)
Study Director: AMEL OUSLIMANI, PM Assistance Publique - Hôpitaux de Paris, DRCD

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02494531     History of Changes
Other Study ID Numbers: P120134
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Alzheimer Disease
PET
diagnosis
MCI
illiterate

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Fluorodeoxyglucose F18
Deoxyglucose
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents