Clinical trial NCT02492529: Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Official title: Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer, Recognition Memory, Mild Cognitive Impairment, fMRI
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group
timeFrame: 3 months
measure: Significant effect of the familiarity vs novelty condition on the pattern of % BOLD signal change in across the brain in the AD-MCI group
timeFrame: 3 months
Secondary outcomes:
measure: Significant group effect on the pattern of % BOLD signal change in across the brain
timeFrame: 3 months
measure: Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
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.