Prospective Memory Imaging (IMPRO)

Cerebral Substrates of Prospective Memory in Healthy Young Adults and Disruptions in Normal Aging and Alzheimer Disease: a Study in Anatomical, Functional and Diffusion Tensor MRI.

The purpose of this study is to investigate prospective merory (memory of intentions) in healthy controls and in aMCI (amnestic Mild Cognitive Impairment) and AD (Alzheimer Disease) patients.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • University Hospital Côte de Nacre
  • Calvados
    • Caen, Calvados, France, 14000
      • Active, not recruiting
      • GIP Cyceron
    • Caen, Calvados, France, 14000
      • Active, not recruiting
      • MRSH - University of Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria :

• Education level > 7 years
• Native language: French
• Beck < 7

• Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:

  • Young Healthy Subjects: between 18 and 44 years old;
  • Middle age Healthy Subjects: between 45 and 69 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
  • Elderly Healthy Subjects: over 70 years old, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
  • MCI patients: over 50 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
  • Alzheimer's patients: over 50 years old, presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 18).

Exclusion Criteria :

• The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
• A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
• A history of major disease (a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
• A medication that may interfere with memory or metabolic measures
• A alcohol or drugs abuse
• claustrophobia, metallic object in the body
• A predominantly left-hand (score below 50% in Edinburgh Inventory).
• Protected adults, and persons not affiliated with a social security system will not participate in this study.
• Pregnant or suckling women
• The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Cognitive Impairment patients	Behavioral: Memory assessment; Neuropsychological tests including clinical and original tests to compare differences between each populations; Other: Structural MRI; to compare differences between each populations; Other: Functional MRI; to compare differences between each populations; Other: Virtual reality / Memory assessment; to compare differences between each populations
Experimental: Alzheimer Disease patients	Behavioral: Memory assessment; Neuropsychological tests including clinical and original tests to compare differences between each populations; Other: Structural MRI; to compare differences between each populations; Other: Functional MRI; to compare differences between each populations; Other: Virtual reality / Memory assessment; to compare differences between each populations
Experimental: Young Healthy Subjects	Behavioral: Memory assessment; Neuropsychological tests including clinical and original tests to compare differences between each populations; Other: Structural MRI; to compare differences between each populations; Other: Functional MRI; to compare differences between each populations; Other: Virtual reality / Memory assessment; to compare differences between each populations
Experimental: Middle age Healthy Subjects	Behavioral: Memory assessment; Neuropsychological tests including clinical and original tests to compare differences between each populations; Other: Structural MRI; to compare differences between each populations; Other: Functional MRI; to compare differences between each populations; Other: Virtual reality / Memory assessment; to compare differences between each populations
Experimental: Elderly Healthy Subjects	Behavioral: Memory assessment; Neuropsychological tests including clinical and original tests to compare differences between each populations; Other: Structural MRI; to compare differences between each populations; Other: Functional MRI; to compare differences between each populations; Other: Virtual reality / Memory assessment; to compare differences between each populations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of volume change of whole brain and other structural MRI measures	1 Month
Cerebral regions implicated in prospective memory observed by functional MRI	1 Month
Episodic memory as measured by Cognitive Tests	18 Months
Virtual reality evaluation of prospective memory	1 Month
Group differences for each imaging and neuropsychological measurement	1 Month

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 12, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Alzheimer Disease; Brain Imaging; Prospective Memory; Healthy Aging
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2010-A00031-38