COSIMAGE: Social Cognition in Ageing and in Frontotemporal Lobar Degeneration

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01962064

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the age and the neurodegenerative disease effects on social cognition. Secondary goals are to better understand the relationships between different component of social cognition, executive functioning, and behavior and describing the neuronal substrates associated to the alteration of the social cognition in ageing and dementia.

Condition or Disease	Intervention/Treatment	Phase
Frontotemporal Lobar Degeneration Aging	Behavioral: Cognitive assessment Other: Brain imaging examination MRI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Social Cognition in Ageing and in Frontotemporal Lobar Degeneration (Frontotemporal Dementia and Semantic Dementia): a Cognitive and Neuroimaging Study

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semantic demantia cognitive assessment and Brain imaging examination MRI of patient with the semantic variant of primary progressive aphasia	Behavioral: Cognitive assessment Other: Brain imaging examination MRI
Experimental: Frontotemporal dementia cognitive assessment and Brain imaging examination MRI of patients with the behavioral variant of frontotemporal lobar degeneration	Behavioral: Cognitive assessment Other: Brain imaging examination MRI
Experimental: Elderly cognitive assessment and Brain imaging examination MRI of healthy elderly subjects	Behavioral: Cognitive assessment Other: Brain imaging examination MRI
Experimental: Young cognitive assessment and Brain imaging examination MRI of young subjects	Behavioral: Cognitive assessment Other: Brain imaging examination MRI

Outcome Measures

Primary Outcome Measures

Social cognition scores [2 years]
number of correct responses in a social cognition test

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All the participants
Age between 40 and 80 years
Minimum of 7 years of education
French native speaker
Healthy subjects
Non pathological Dementia rating scale score
Patients
Clinical diagnosis of frontotemporal lobar degeneration

Exclusion Criteria:

Chronic neurological disease
Encephalitis
Endocrinal disease
Hepatic disease
Case history of head injury with loss of consciousness of more than one hour
Case history of stroke
Case history of cancer during the five last years except squamous cell carcinomas
Alcoholism or drug addiction
Major psychiatric disorders according the Diagnostic and Statistical Manual of Mental Disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inserm - EPHE - University of Caen U1077	Caen		France	14000

Sponsors and Collaborators

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

Investigators

Principal Investigator: Vincent de La Sayette, MD, University Hospital, Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT01962064

Other Study ID Numbers:

2011-A00681-40

First Posted:

Oct 14, 2013

Last Update Posted:

Oct 14, 2013

Last Verified:

Oct 1, 2013

Additional relevant MeSH terms:

Frontotemporal Lobar Degeneration

Study Results

No Results Posted as of Oct 14, 2013