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

October 10, 2013 updated by: University Hospital, Caen

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Caen, France, 14000
        • Recruiting
        • Inserm - EPHE - University of Caen U1077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social cognition scores
Time Frame: 2 years
number of correct responses in a social cognition test
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

October 14, 2013

Last Update Submitted That Met QC Criteria

October 10, 2013

Last Verified

October 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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