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

Primary Purpose

Frontotemporal Lobar Degeneration, Aging

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive assessment
Brain imaging examination MRI
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frontotemporal Lobar Degeneration

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Inserm - EPHE - University of Caen U1077Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Semantic demantia

Frontotemporal dementia

Elderly

Young

Arm Description

cognitive assessment and Brain imaging examination MRI of patient with the semantic variant of primary progressive aphasia

cognitive assessment and Brain imaging examination MRI of patients with the behavioral variant of frontotemporal lobar degeneration

cognitive assessment and Brain imaging examination MRI of healthy elderly subjects

cognitive assessment and Brain imaging examination MRI of young subjects

Outcomes

Primary Outcome Measures

Social cognition scores
number of correct responses in a social cognition test

Secondary Outcome Measures

Full Information

First Posted
September 3, 2013
Last Updated
October 10, 2013
Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01962064
Brief Title
Social Cognition in Ageing and in Frontotemporal Lobar Degeneration
Acronym
COSIMAGE
Official Title
Social Cognition in Ageing and in Frontotemporal Lobar Degeneration (Frontotemporal Dementia and Semantic Dementia): a Cognitive and Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Lobar Degeneration, Aging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semantic demantia
Arm Type
Experimental
Arm Description
cognitive assessment and Brain imaging examination MRI of patient with the semantic variant of primary progressive aphasia
Arm Title
Frontotemporal dementia
Arm Type
Experimental
Arm Description
cognitive assessment and Brain imaging examination MRI of patients with the behavioral variant of frontotemporal lobar degeneration
Arm Title
Elderly
Arm Type
Experimental
Arm Description
cognitive assessment and Brain imaging examination MRI of healthy elderly subjects
Arm Title
Young
Arm Type
Experimental
Arm Description
cognitive assessment and Brain imaging examination MRI of young subjects
Intervention Type
Behavioral
Intervention Name(s)
Cognitive assessment
Intervention Type
Other
Intervention Name(s)
Brain imaging examination MRI
Primary Outcome Measure Information:
Title
Social cognition scores
Description
number of correct responses in a social cognition test
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Chavant
Phone
231065495
Ext
+33
Email
memoire-rechcerche.caen@inserm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent de La Sayette, MD
Organizational Affiliation
University Hospital, Caen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inserm - EPHE - University of Caen U1077
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Social Cognition in Ageing and in Frontotemporal Lobar Degeneration

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