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

Alzheimer's Disease Clinical Trial

— EPMR-MA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492529
• Other study ID #: 2014-A01123-44
• Secondary ID: 35RC14_9777_EPMR
• Status: Completed
• Phase: N/A
• Start date: July 21, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• 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

Device:
• A cranial MRI

Other:
• Experimental procedure

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & 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.neurob — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of recognition memory accuracy measures under the familiarity condition as compared with the novel condition in the AD-MCI group		3 months
Primary	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	Significant group effect on the pattern of % BOLD signal change in across the brain		3 months
Secondary	Predictive validity of the brain % BOLD signal change pattern for participants clinical status (i.e. controls vs. AD-MCI)		3 months
Secondary	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