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Completed

NCT Number: NCT02492529

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

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

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

A cranial MRI

Device

Experimental procedure

Other

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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: EPMR-MA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 8, 2015
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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