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Prospective Memory Imaging (IMPRO)

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ClinicalTrials.gov Identifier: NCT01638884
Recruitment Status : Unknown
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : July 12, 2012
Last Update Posted : April 9, 2014
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: Memory assessment Other: Structural MRI Other: Functional MRI Other: Virtual reality / Memory assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : September 2010
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Rate of volume change of whole brain and other structural MRI measures [ Time Frame: 1 Month ]
  2. Cerebral regions implicated in prospective memory observed by functional MRI [ Time Frame: 1 Month ]
  3. Episodic memory as measured by Cognitive Tests [ Time Frame: 18 Months ]
  4. Virtual reality evaluation of prospective memory [ Time Frame: 1 Month ]
  5. Group differences for each imaging and neuropsychological measurement [ Time Frame: 1 Month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638884


Contacts
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Contact: Julien Chavant +33231065495 memoire-recherche.caen@inserm.fr

Locations
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France
GIP Cyceron Active, not recruiting
Caen, Calvados, France, 14000
MRSH - University of Caen Active, not recruiting
Caen, Calvados, France, 14000
University Hospital Côte de Nacre Recruiting
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Vincent de La Sayette, MD University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01638884     History of Changes
Other Study ID Numbers: 2010-A00031-38
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by University Hospital, Caen:
Prospective Memory
Healthy Aging
Alzheimer Disease
Brain Imaging

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders