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

NCT ID: NCT02492529

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-21

Study Completion Date

2017-12-31

Brief Summary

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Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

Detailed Description

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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

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Neuropsychological tests

Intervention Type OTHER

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

Experimental procedure

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Neuropsychological tests

Intervention Type OTHER

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 MRI

Intervention Type DEVICE

Experimental procedure

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Neuropsychological tests

Intervention Type OTHER

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 MRI

Intervention Type DEVICE

Experimental procedure

Intervention Type OTHER

Interventions

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Neuropsychological 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

Intervention Type OTHER

A cranial MRI

Intervention Type DEVICE

Experimental procedure

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34837869 (View on PubMed)

Other Identifiers

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35RC14_9777_EPMR-MA

Identifier Type: OTHER

Identifier Source: secondary_id

2014-A01123-44

Identifier Type: -

Identifier Source: org_study_id

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