Clinical trial NCT01638884: Prospective Memory Imaging
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
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Prospective Memory
Healthy Aging
Alzheimer Disease
Brain Imaging
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-07-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Rate of volume change of whole brain and other structural MRI measures
timeFrame: 1 Month
measure: Cerebral regions implicated in prospective memory observed by functional MRI
timeFrame: 1 Month
measure: Episodic memory as measured by Cognitive Tests
timeFrame: 18 Months
measure: Virtual reality evaluation of prospective memory
timeFrame: 1 Month
measure: Group differences for each imaging and neuropsychological measurement
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: GIP Cyceron
state: Calvados
city: Caen
country: France
facility: MRSH - University of Caen
state: Calvados
city: Caen
country: France
facility: University Hospital Côte de Nacre
Study officials:
affiliation: University Hospital, Caen
name: Vincent de La Sayette, MD
role: PRINCIPAL_INVESTIGATOR
References: