Social Cognition in Ageing and in Frontotemporal Lobar Degeneration

Aging Clinical Trial

— COSIMAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01962064
• Other study ID #: 2011-A00681-40
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2013
• Last updated: October 10, 2013
• Start date: June 2013
• Est. completion date: November 2014

Study information

• Verified date: October 2013
• Source: University Hospital, Caen
• Contact: Julien Chavant
• Phone: 231065495
• Email: memoire-rechcerche.caen[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Aging
• Frontotemporal Lobar Degeneration

Intervention

Behavioral:
• Cognitive assessment

Other:
• Brain imaging examination MRI

Locations

Country	Name	City	State
France	Inserm - EPHE - University of Caen U1077	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	Social cognition scores	number of correct responses in a social cognition test	2 years	No

External Links

•   Team web site