Social Cognition in Ageing and in Frontotemporal Lobar Degeneration (COSIMAGE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Caen
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01962064
First received: September 3, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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 Intervention
Frontotemporal Lobar Degeneration
Aging
Behavioral: Cognitive assessment
Other: Brain imaging examination MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Social cognition scores [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    number of correct responses in a social cognition test


Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962064

Contacts
Contact: Julien Chavant 231065495 ext +33 memoire-rechcerche.caen@inserm.fr

Locations
France
Inserm - EPHE - University of Caen U1077 Recruiting
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
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01962064     History of Changes
Other Study ID Numbers: 2011-A00681-40
Study First Received: September 3, 2013
Last Updated: October 10, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Frontotemporal Lobar Degeneration
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Proteostasis Deficiencies
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 23, 2014