Alzheimer DiseaseAVILLNCT02494531
Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging
A study testing Fluorodeoxyglucose-PET and florbetapir F 18-PET in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Fluorodeoxyglucose-PET and florbetapir F 18-PET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2015to 6 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Fluorodeoxyglucose-PET, florbetapir F 18-PET
- Keywords
- Alzheimer Disease, PET, diagnosis, MCI, illiterate
- Medical subject headings
- Alzheimer Disease, Disease, Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorodeoxyglucose-PETRadiation
Fluorodeoxyglucose-PET performed within 2 months
florbetapir F 18-PETRadiation
florbetapir F 18-PET performed within 2 months
| Study group | Role | What they receive |
|---|---|---|
| Positon Emission Tomographic (PET)-scan | Other | 2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET Receives: Radiation: Fluorodeoxyglucose-PET; Radiation: florbetapir F 18-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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,
Comparison of florbetapir-18 Fluor SUV (Standardized Uptake Values) ratios (max and mean of SUVr) in the different groups as defined above
Measured: Within 2 months after inclusion
Comparison of the amyloid deposit location between the 2 groups (literate and illiterate)
Group comparison of qualitative topography of amyloid burden
Measured: Within 2 months after inclusion
correlation between amyloid load and metabolism dysfunction using Fluorodeoxyglucose (FDG)-PET in each groups
Group comparison of topography of amyloid deposit and FDG metabolism
Measured: Within 2 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start12 Dec 2015
- Primary completion6 May 2019
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Belin, Dr, Principal investigator, ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)AMEL OUSLIMANI, PM, Study director, Assistance Publique - Hôpitaux de Paris, DRCD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494531
- Sponsor's protocol ID
- P120134
- Acronym
- AVILL
- Status last verified
- Dec 2020
- First submitted
- 4 May 2015
- Last updated
- 13 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging
- ClinicalTrials.gov ID
- NCT02494531
- Acronym / sponsor ID
- AVILL / P120134
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, PET, diagnosis, MCI, illiterate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Dec 2015 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positon Emission Tomographic (PET)-scan | Other | Radiation: Fluorodeoxyglucose-PET, Radiation: florbetapir F 18-PET2 PET-scan: Fluorodeoxyglucose-PET and florbetapir F 18-PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For all patients enrolled in the study:
- 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.
- For AD patients
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorodeoxyglucose-PETFluorodeoxyglucose-PET performed within 2 months | Radiation | Positon Emission Tomographic (PET)-scan |
| florbetapir F 18-PETflorbetapir F 18-PET performed within 2 months | Radiation | Positon Emission Tomographic (PET)-scan |
Primary outcome
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
3 secondary outcomes
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 the amyloid deposit location between the 2 groups (literate and illiterate)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Belin, Dr principal investigator
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (hospial Avicenne)
AMEL OUSLIMANI, PM study director
Assistance Publique - Hôpitaux de Paris, DRCD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorodeoxyglucose-PET and florbetapir F 18-PET in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.