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Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease (EPMR-MA)

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological tests
A cranial MRI
Experimental procedure
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer's Disease focused on measuring Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

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)

Sites / Locations

  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Healthy volunteers

Patients with early Alzheimer disease

Old healthy volunteers

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group
Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group

Secondary Outcome Measures

Significant group effect on the pattern of % BOLD signal change in across the brain
Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)
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)

Full Information

First Posted
November 18, 2014
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02492529
Brief Title
Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Acronym
EPMR-MA
Official Title
Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
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
Arm Title
Patients with early Alzheimer disease
Arm Type
Experimental
Arm Description
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
Arm Title
Old healthy volunteers
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Neuropsychological tests
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
A cranial MRI
Intervention Type
Other
Intervention Name(s)
Experimental procedure
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Significant group effect on the pattern of % BOLD signal change in across the brain
Time Frame
3 months
Title
Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)
Time Frame
3 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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)
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34837869
Citation
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.
Results Reference
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Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

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