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CompletedNCT02492529EPMR-MAUpdated May 24, 2023

Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

An interventional study of Neuropsychological tests and A cranial MRI in Alzheimer's Disease, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
25 Years to 75 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI
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In context

Alzheimer Disease

3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 2,809 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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
  • 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

Exclusion criteria

Exclusion Criteria:

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

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)
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    Healthy volunteers

    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

    Other: Neuropsychological tests · Other: Experimental procedure

  • Experimental
    Patients with early Alzheimer disease

    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

    Other: Neuropsychological tests · Device: A cranial MRI · Other: Experimental procedure

  • Experimental
    Old healthy volunteers

    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

    Other: Neuropsychological tests · Device: A cranial MRI · Other: Experimental procedure

Interventions

  • OtherNeuropsychological tests

    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

  • DeviceA cranial MRI
  • OtherExperimental procedure
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What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Significant group effect on the pattern of % BOLD signal change in across the brain

    Time frame: 3 months

  2. Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)

    Time frame: 3 months

  3. 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

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Study locations

1 site
  • Centre Hospitalier Universitaire
    Rennes, 35033, France
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02492529
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Jul 8, 2015
Start date
Jul 21, 2015
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
May 24, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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