Alzheimer's DiseaseEPMR-MANCT02492529
Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
A study testing Neuropsychological tests, A cranial MRI and Experimental procedure in people with Alzheimer's Disease, run by Rennes University Hospital at 1 site in France.
Trial summary
Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Neuropsychological tests, A cranial MRI and Experimental procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2015to 31 Dec 2017
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers (pilot phase)
- Aged 25 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
- Free from any medical or psychiatric condition that may impact cognition
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- Having given written informed consent
- Volunteers (experimental phase)
- Aged 60 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
- Free from any medical or psychiatric condition that may impact cognition
- Having given written informed consent
- AD-MCI participants
- Aged 60 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
- Fulfilling criteria for " AD-MCI " (Albert et al., 2011)
- Have been seen in a memory medical center or in Memory Resources and Research Medical Center for cognitive symptoms
- Free from any medical or psychiatric condition that may impact cognition
- Able to understand and consent
- Having given written informed consent
Who cannot join
- MRI contraindications (all participants)
- Claustrophobia
- Wearing of any metal implant such as:
- Heart pacemaker
- Iron-magnetic surgical clips
- Any metallic foreign body in the eye or brain
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- Other criteria (all participants)
- Significant history of neurological or psychiatric disorders
- Ongoing medication that may affect cognitive performances
- Sensory deficit that may interfere with the experimental design (e.g. uncorrected visual impairment)
- Lack of sufficient cooperation during the cognitive tasks
- Persons under major legal protection and/or deprived of liberty
- Other criteria (control participants)
- Global cognitive impairment attested by Mattis Dementia Rating Scale or Mini-Mental State Examination, according to available normative data
- Other criteria (AD-MCI participants)
- 7 items modified Hachinski ischemic score > 2 (Hachinski et al., 2012)
- Dementia (McKahn, et al., 2011)
Trial locations and contacts
1 site in 1 country.
About this study
Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.
Read the detailed description
Prospective functional Magnetic Resonance Imaging study involving a group of participants with Mild Cognitive Impairment due to AD and a control participants group matched for age, education level, verbal Intelligence Quotient as assessed through the French version of the National Adult Reading Test and income group following National Institute of Statistics and Economics Studies classification.
- Conditions
- Alzheimer's Disease
- Being tested
- Neuropsychological tests, A cranial MRI, Experimental procedure
- Keywords
- Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsOther
Scales and tests to evaluate:
- Global cognitive performance
- Handedness
- Memory functions performance
- Gestural praxis functions performance
- Lexical and semantic functions performance
- Executive functions performance
- Memory disorders
- Way of life
- Mood
A cranial MRIDevice
Experimental procedureOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | 60 old healthy volunteers (aged 25-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria.
Then will be performed:
* Neuropsychological tests
* Experimental procedure Receives: Other: Neuropsychological tests; Other: Experimental procedure |
| Patients with early Alzheimer disease | Experimental | 20 patients (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria.
Then will be performed:
* Neuropsychological tests
* Experimental procedure
* A cranial MRI Receives: Other: Neuropsychological tests; Device: A cranial MRI; Other: Experimental procedure |
| Old healthy volunteers | Experimental | 20 healthy volunteers (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria.
Then will be performed:
* Neuropsychological tests
* Experimental procedure
* A cranial MRI Receives: Other: Neuropsychological tests; Device: A cranial MRI; Other: Experimental procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group
Measured: 3 months
Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group
Measured: 3 months
Secondary outcomes (3)
Significant group effect on the pattern of % BOLD signal change in across the brain
Measured: 3 months
Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)
Measured: 3 months
Significant interaction between the kind of familiarity condition (i.e. novel, experimental or pre-experimental) and the estimates of recognition memory processes efficiency (i.e. respective contributions of recollection and familiarity, % correct)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study start21 Jul 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492529
- Sponsor's protocol ID
- 2014-A01123-44
- Other IDs
- 35RC14_9777_EPMR-MA
- Acronym
- EPMR-MA
- Status last verified
- May 2023
- First submitted
- 18 Nov 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Jonin PY, Duche Q, Bannier E, Corouge I, Ferre JC, Belliard S, Barillot C, Barbeau EJ. Building memories on prior knowledge: behavioral and fMRI evidence of impairment in early Alzheimer's disease. Neurobiol Aging. 2022 Feb;110:1-12. doi: 10.1016/j.neurobiolaging.2021.10.013. Epub 2021 Oct 29.
PubMed 34837869
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02492529
- Acronym / sponsor ID
- EPMR-MA / 2014-A01123-44
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 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.
Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.
Detailed description
Prospective functional Magnetic Resonance Imaging study involving a group of participants with Mild Cognitive Impairment due to AD and a control participants group matched for age, education level, verbal Intelligence Quotient as assessed through the French version of the National Adult Reading Test and income group following National Institute of Statistics and Economics Studies classification.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Neuropsychological tests, Other: Experimental procedure60 old healthy volunteers (aged 25-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure |
| Patients with early Alzheimer disease | Experimental | Other: Neuropsychological tests, Device: A cranial MRI, Other: Experimental procedure20 patients (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI |
| Old healthy volunteers | Experimental | Other: Neuropsychological tests, Device: A cranial MRI, Other: Experimental procedure20 healthy volunteers (aged 60-75) will undergo an inclusion visit in order to check inclusion and non inclusion criteria. Then will be performed: * Neuropsychological tests * Experimental procedure * A cranial MRI |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Volunteers (pilot phase)
- Aged 25 - 75
- French native speakers
- Right-handed
- Education level equal or superior to primary school leaving certificate
Key exclusion criteria (17 listed)
- MRI contraindications (all participants)
- Claustrophobia
- Wearing of any metal implant such as:
- Other criteria (all participants)
- Significant history of neurological or psychiatric disorders
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 |
|---|---|---|
| Neuropsychological testsScales and tests to evaluate: * Global cognitive performance * Handedness * Memory functions performance * Gestural praxis functions performance * Lexical and semantic functions performance * Executive functions performance * Memory disorders * Way of life * Mood | Other | Healthy volunteers, Old healthy volunteers, Patients with early Alzheimer disease |
| A cranial MRI | Device | Old healthy volunteers, Patients with early Alzheimer disease |
| Experimental procedure | Other | Healthy volunteers, Old healthy volunteers, Patients with early Alzheimer disease |
Primary outcome
Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group
Time frame: 3 months
Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group
Time frame: 3 months
3 secondary outcomes
Significant group effect on the pattern of % BOLD signal change in across the brain
Time frame: 3 months
Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)
Time frame: 3 months
Significant interaction between the kind of familiarity condition (i.e. novel, experimental or pre-experimental) and the estimates of recognition memory processes efficiency (i.e. respective contributions of recollection and familiarity, % correct)
Time frame: 3 months
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 24 May 2023.
- Results publication: PubMed 34837869Jonin PY, Duche Q, Bannier E, Corouge I, Ferre JC, Belliard S, Barillot C, Barbeau EJ. Building memories on prior knowledge: behavioral and fMRI evidence of impairment in early Alzheimer's disease. Neurobiol Aging. 2022 Feb;110:1-12. doi: 10.1016/j.neurobiolaging.2021.10.013. Epub 2021 Oct 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests, A cranial MRI and Experimental procedure in people with Alzheimer's Disease, run by Rennes University Hospital 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 24 inclusion and 17 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 24 May 2023. 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?
Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02492529, which also lists 1 linked publication.
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 24 May 2023.