Prospective Memory Imaging (IMPRO)

April 8, 2014 updated by: University Hospital, Caen

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 Month
1 Month
Cerebral regions implicated in prospective memory observed by functional MRI
Time Frame: 1 Month
1 Month
Episodic memory as measured by Cognitive Tests
Time Frame: 18 Months
18 Months
Virtual reality evaluation of prospective memory
Time Frame: 1 Month
1 Month
Group differences for each imaging and neuropsychological measurement
Time Frame: 1 Month
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A00031-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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