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

NCT02492529 | Completed

• 2 other identifiers: 2014-A01123-4435RC14_9777_EPMR-MA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI

Outcome Measures

Primary Outcomes (2)

• Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group

  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

  3 months

Secondary Outcomes (3)

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

  3 months

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

  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)

  3 months

Study Arms (3)

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

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

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

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

Interventions

Neuropsychological tests 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

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

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Centre Hospitalier Universitaire

Rennes, 35033, France

Location

Related Publications (1)

• 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.

  PMID: 34837869 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: July 8, 2015
• Study Start: July 21, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (1)