- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962064
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Julien Chavant
- Phone Number: +33 231065495
- Email: memoire-rechcerche.caen@inserm.fr
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A00681-40
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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