Prospective Memory Imaging

NCT01638884 | Unknown DMC

• 1 other identifier: 2010-A00031-38
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer Disease

Keywords

Prospective Memory; Healthy Aging; Alzheimer Disease; Brain Imaging

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (5)

Young Healthy Subjects

EXPERIMENTAL

Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment

Middle age Healthy Subjects

EXPERIMENTAL

Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment

Elderly Healthy Subjects

EXPERIMENTAL

Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment

Mild Cognitive Impairment patients

EXPERIMENTAL

Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment

Alzheimer Disease patients

EXPERIMENTAL

Behavioral: Memory assessment; Other: Structural MRI; Other: Functional MRI; Other: Virtual reality / Memory assessment

Interventions

Memory assessment BEHAVIORAL

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

Alzheimer Disease patients; Elderly Healthy Subjects; Middle age Healthy Subjects; Mild Cognitive Impairment patients; Young Healthy Subjects

Structural MRI OTHER

to compare differences between each populations

Alzheimer Disease patients; Elderly Healthy Subjects; Middle age Healthy Subjects; Mild Cognitive Impairment patients; Young Healthy Subjects

Functional MRI OTHER

to compare differences between each populations

Alzheimer Disease patients; Elderly Healthy Subjects; Middle age Healthy Subjects; Mild Cognitive Impairment patients; Young Healthy Subjects

Virtual reality / Memory assessment OTHER

to compare differences between each populations

Alzheimer Disease patients; Elderly Healthy Subjects; Middle age Healthy Subjects; Mild Cognitive Impairment patients; Young Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (3)

GIP Cyceron

Caen, Calvados, 14000, France

ACTIVE NOT RECRUITING

MRSH - University of Caen

Caen, Calvados, 14000, France

ACTIVE NOT RECRUITING

University Hospital Côte de Nacre

Caen, 14033, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Vincent de La Sayette, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Chavant

CONTACT

+33231065495; memoire-recherche.caen@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: September 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

FR (3)