Prospective Memory Imaging (IMPRO)
Primary Purpose
Alzheimer Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Memory assessment
Structural MRI
Functional MRI
Virtual reality / Memory assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Prospective Memory, Healthy Aging, Alzheimer Disease, Brain Imaging
Eligibility 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)
Sites / Locations
- GIP Cyceron
- MRSH - University of Caen
- University Hospital Côte de NacreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Young Healthy Subjects
Middle age Healthy Subjects
Elderly Healthy Subjects
Mild Cognitive Impairment patients
Alzheimer Disease patients
Arm Description
Outcomes
Primary Outcome Measures
Rate of volume change of whole brain and other structural MRI measures
Cerebral regions implicated in prospective memory observed by functional MRI
Episodic memory as measured by Cognitive Tests
Virtual reality evaluation of prospective memory
Group differences for each imaging and neuropsychological measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT01638884
First Posted
July 10, 2012
Last Updated
April 8, 2014
Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01638884
Brief Title
Prospective Memory Imaging
Acronym
IMPRO
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Prospective Memory, Healthy Aging, Alzheimer Disease, Brain Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Young Healthy Subjects
Arm Type
Experimental
Arm Title
Middle age Healthy Subjects
Arm Type
Experimental
Arm Title
Elderly Healthy Subjects
Arm Type
Experimental
Arm Title
Mild Cognitive Impairment patients
Arm Type
Experimental
Arm Title
Alzheimer Disease patients
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Memory assessment
Intervention Description
Neuropsychological tests including clinical and original tests to compare differences between each populations
Intervention Type
Other
Intervention Name(s)
Structural MRI
Intervention Description
to compare differences between each populations
Intervention Type
Other
Intervention Name(s)
Functional MRI
Intervention Description
to compare differences between each populations
Intervention Type
Other
Intervention Name(s)
Virtual reality / Memory assessment
Intervention Description
to compare differences between each populations
Primary Outcome Measure Information:
Title
Rate of volume change of whole brain and other structural MRI measures
Time Frame
1 Month
Title
Cerebral regions implicated in prospective memory observed by functional MRI
Time Frame
1 Month
Title
Episodic memory as measured by Cognitive Tests
Time Frame
18 Months
Title
Virtual reality evaluation of prospective memory
Time Frame
1 Month
Title
Group differences for each imaging and neuropsychological measurement
Time Frame
1 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Chavant
Phone
+33231065495
Email
memoire-recherche.caen@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent de La Sayette, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
GIP Cyceron
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
MRSH - University of Caen
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Prospective Memory Imaging
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