Prospective Memory Imaging

NCT ID: NCT01638884

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Young Healthy Subjects

Group Type EXPERIMENTAL

Memory assessment

Intervention Type BEHAVIORAL

Neuropsychological tests including clinical and original tests to compare differences between each populations

Structural MRI

Intervention Type OTHER

to compare differences between each populations

Functional MRI

Intervention Type OTHER

to compare differences between each populations

Virtual reality / Memory assessment

Intervention Type OTHER

to compare differences between each populations

Middle age Healthy Subjects

Group Type EXPERIMENTAL

Memory assessment

Intervention Type BEHAVIORAL

Neuropsychological tests including clinical and original tests to compare differences between each populations

Structural MRI

Intervention Type OTHER

to compare differences between each populations

Functional MRI

Intervention Type OTHER

to compare differences between each populations

Virtual reality / Memory assessment

Intervention Type OTHER

to compare differences between each populations

Elderly Healthy Subjects

Group Type EXPERIMENTAL

Memory assessment

Intervention Type BEHAVIORAL

Neuropsychological tests including clinical and original tests to compare differences between each populations

Structural MRI

Intervention Type OTHER

to compare differences between each populations

Functional MRI

Intervention Type OTHER

to compare differences between each populations

Virtual reality / Memory assessment

Intervention Type OTHER

to compare differences between each populations

Mild Cognitive Impairment patients

Group Type EXPERIMENTAL

Memory assessment

Intervention Type BEHAVIORAL

Neuropsychological tests including clinical and original tests to compare differences between each populations

Structural MRI

Intervention Type OTHER

to compare differences between each populations

Functional MRI

Intervention Type OTHER

to compare differences between each populations

Virtual reality / Memory assessment

Intervention Type OTHER

to compare differences between each populations

Alzheimer Disease patients

Group Type EXPERIMENTAL

Memory assessment

Intervention Type BEHAVIORAL

Neuropsychological tests including clinical and original tests to compare differences between each populations

Structural MRI

Intervention Type OTHER

to compare differences between each populations

Functional MRI

Intervention Type OTHER

to compare differences between each populations

Virtual reality / Memory assessment

Intervention Type OTHER

to compare differences between each populations

Interventions

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Memory assessment

Neuropsychological tests including clinical and original tests to compare differences between each populations

Intervention Type BEHAVIORAL

Structural MRI

to compare differences between each populations

Intervention Type OTHER

Functional MRI

to compare differences between each populations

Intervention Type OTHER

Virtual reality / Memory assessment

to compare differences between each populations

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent de La Sayette, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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GIP Cyceron

Caen, Calvados, France

Site Status ACTIVE_NOT_RECRUITING

MRSH - University of Caen

Caen, Calvados, France

Site Status ACTIVE_NOT_RECRUITING

University Hospital Côte de Nacre

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien Chavant

Role: CONTACT

+33231065495

Other Identifiers

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2010-A00031-38

Identifier Type: -

Identifier Source: org_study_id

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