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

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ClinicalTrials.gov Identifier: NCT01962064
Recruitment Status : Unknown
Verified October 2013 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : October 14, 2013
Last Update Posted : October 14, 2013
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Caen

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : November 2014


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



Primary Outcome Measures :
  1. Social cognition scores [ Time Frame: 2 years ]
    number of correct responses in a social cognition test



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01962064     History of Changes
Other Study ID Numbers: 2011-A00681-40
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

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