Plaque, AmyloidEDUMANCT02196116
Amyloïd Load in Elderly Population: Effect of Cognitive Reserve
A study testing PET, MRI and neuropsychological tests in people with Plaque, Amyloid and Cognitive Deficits, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque, Amyloid, Cognitive Deficits
- What is being tested?
- PET, MRI and neuropsychological tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jul 2016
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participation in the AMI or 3C cohorts Group 1- Controls
- MMSE > 24 or > 26 for low and high levels of education, respectively.
- Without memory impairment (for episodic memory) on the Free and Cued Selective Reminding Test RL/RI-16 items (FCSRT), free recall > 22 and total recall >42, according to the thresholds for population-based studies
- Without memory complaint
- Without dementia Group 2- Cognitively-impaired subjects without dementia and without memory complaints
- Mini Mental State Evaluation (MMSE) < 24 or < 26 for low and high levels of education, respectively
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- With memory impairments according to the RL/RI-16 test (free recall≤22 and/or total recall ≤42), according to the thresholds for population-based studies defined by Auriacombe et al., 2010.
- Without memory complaint
- Without dementia Group 3- Cognitively-impaired subjects without dementia and with memory complaints
- MMSE < 24 or < 26 for low and high levels of education, respectively
- With memory impairments according to the RL/RI-16 test (same thresholds as above)
- With memory complaint
- Without dementia
Who cannot join
- Being left handed
- Presence of dementia (based on the clinical diagnosis)
- Presence of stroke
- Presence of Parkinson's disease
- Presence of a counter-indication for MRI
- Presence of a counter-indication for PET Scan with [18F]-Flutemetamol
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- Presence of any health problem preventing travel to the imaging service of the University Hospital
- Being under the legal guardianship of another person or being unable to provide consent to participate
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
Michèle ALLARD, MD-PhD contact
Caroline BUISSON, CRA contact
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Michele ALLARD, MD, michele.allard@chu-bordeaux.fr
Michèle ALLARD, MD, PhD
About this study
This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based cohorts "3C" and "AMIMage" The first group includes cognitively intact participants who will serve as controls, the second group, subjects with mild cognitive impairments without memory complaint and the third, subjects with both mild cognitive impairments and memory complaint.
Read the detailed description
Influence of educational level on the relationship between disease-specific lesion development and cognitive function will be assessed, as measured by amyloid PET imaging and a battery of neuropsychological tests at the very early stages of the disease, comparatively to age-matched controls. In addition, this project will explore the influence of cognitive complaint.
It's assumed that 1) the amyloid-PET measures in age-matched controls and subjects from the two cohorts will correlate with cognitive performances; 2) the amyloid burden will be higher in high- than in low-educated subjects with similar cognitive impairment; and 3) similarly the amyloid burden will be higher in subjects with cognitive complaint compared to subjects without cognitive complaint.
Considering a longer term, the clinical follow-up of study participants will allow to investigate the prognosis value of amyloid load for improving the prediction of cognitive decline and disease progression.
- Conditions
- Plaque, Amyloid, Cognitive Deficits
- Being tested
- PET, MRI, neuropsychological tests
- Keywords
- Alzheimer disease, amyloid load, educational level, cognitive performances
- Medical subject headings
- Plaque, Amyloid, Cognition Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETOther
PET Scan with [18F]-Flutemetamol
MRIOther
neuropsychological testsOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Controls Receives: Other: PET; Other: MRI; Other: neuropsychological tests |
| Group 2 | Experimental | Cognitively-impaired subjects without dementia and without memory Receives: Other: PET; Other: MRI; Other: neuropsychological tests |
| Group 3 | Experimental | Cognitively-impaired subjects without dementia and with memory Receives: Other: PET; Other: MRI; Other: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid load
Measured: at inclusion (day 0)
Secondary outcomes (3)
Neuropsychological scores
Measured: At inclusion (Day 0)
Educational level
Measured: At inclusion (Day 0)
Memory complaint
Measured: At inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, AmyloidStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Plan Alzheimer, General Electric
- Responsible party
- Sponsor
- Investigators
- Michèle ALLARD, MD-PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196116
- Sponsor's protocol ID
- CHUBX 2013/02
- Acronym
- EDUMA
- Status last verified
- Feb 2015
- First submitted
- 17 Jul 2014
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloïd Load in Elderly Population: Effect of Cognitive Reserve
- ClinicalTrials.gov ID
- NCT02196116
- Acronym / sponsor ID
- EDUMA / CHUBX 2013/02
- Conditions
- Plaque, Amyloid, Cognitive Deficits
- Keywords
- Alzheimer disease, amyloid load, educational level, cognitive performances
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fondation Plan Alzheimer, General Electric
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Jul 2014 (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.
This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based cohorts "3C" and "AMIMage" The first group includes cognitively intact participants who will serve as controls, the second group, subjects with mild cognitive impairments without memory complaint and the third, subjects with both mild cognitive impairments and memory complaint.
Detailed description
Influence of educational level on the relationship between disease-specific lesion development and cognitive function will be assessed, as measured by amyloid PET imaging and a battery of neuropsychological tests at the very early stages of the disease, comparatively to age-matched controls. In addition, this project will explore the influence of cognitive complaint.
It's assumed that 1) the amyloid-PET measures in age-matched controls and subjects from the two cohorts will correlate with cognitive performances; 2) the amyloid burden will be higher in high- than in low-educated subjects with similar cognitive impairment; and 3) similarly the amyloid burden will be higher in subjects with cognitive complaint compared to subjects without cognitive complaint.
Considering a longer term, the clinical follow-up of study participants will allow to investigate the prognosis value of amyloid load for improving the prediction of cognitive decline and disease progression.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: PET, Other: MRI, Other: neuropsychological testsControls |
| Group 2 | Experimental | Other: PET, Other: MRI, Other: neuropsychological testsCognitively-impaired subjects without dementia and without memory |
| Group 3 | Experimental | Other: PET, Other: MRI, Other: neuropsychological testsCognitively-impaired subjects without dementia and with memory |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Participation in the AMI or 3C cohorts Group 1- Controls
- MMSE > 24 or > 26 for low and high levels of education, respectively.
- Without memory impairment (for episodic memory) on the Free and Cued Selective Reminding Test RL/RI-16 items (FCSRT), free recall > 22 and total recall >42, according to the thresholds for population-based studies
- Without memory complaint
- Without dementia Group 2- Cognitively-impaired subjects without dementia and without memory complaints
Key exclusion criteria (9 listed)
- Being left handed
- Presence of dementia (based on the clinical diagnosis)
- Presence of stroke
- Presence of Parkinson's disease
- Presence of a counter-indication for 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 |
|---|---|---|
| PETPET Scan with [18F]-Flutemetamol | Other | Group 1, Group 2, Group 3 |
| MRI | Other | Group 1, Group 2, Group 3 |
| neuropsychological tests | Other | Group 1, Group 2, Group 3 |
Primary outcome
Amyloid load
Time frame: at inclusion (day 0)
3 secondary outcomes
Neuropsychological scores
Time frame: At inclusion (Day 0)
Educational level
Time frame: At inclusion (Day 0)
Memory complaint
Time frame: At inclusion (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
Michèle ALLARD, MD-PhD contact
Caroline BUISSON, CRA contact
Michèle ALLARD, MD-PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET, MRI and neuropsychological tests in people with Plaque, Amyloid and Cognitive Deficits, run by University Hospital, Bordeaux 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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michèle ALLARD, MD-PhD (Michele.allard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloid load (time frame: at inclusion (day 0)). 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 12 Feb 2015.