Prospective Memory Imaging

Alzheimer Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01638884
• Other study ID #: 2010-A00031-38
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2012
• Last updated: April 8, 2014
• Start date: September 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: Julien Chavant
• Phone: +33231065495
• Email: memoire-recherche.caen[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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
• Functional MRI
to compare differences between each populations
• Virtual reality / Memory assessment
to compare differences between each populations

Locations

Country	Name	City	State
France	GIP Cyceron	Caen	Calvados
France	MRSH - University of Caen	Caen	Calvados
France	University Hospital Côte de Nacre	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of volume change of whole brain and other structural MRI measures		1 Month	No
Primary	Cerebral regions implicated in prospective memory observed by functional MRI		1 Month	No
Primary	Episodic memory as measured by Cognitive Tests		18 Months	No
Primary	Virtual reality evaluation of prospective memory		1 Month	No
Primary	Group differences for each imaging and neuropsychological measurement		1 Month	No

External Links

•   Lab web site Inserm U1077