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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01962064
Other study ID # 2011-A00681-40
Secondary ID
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
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