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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01962064
Date of registration: 03/09/2013
Prospective Registration: No
Primary sponsor: University Hospital, Caen
Public title: Social Cognition in Ageing and in Frontotemporal Lobar Degeneration COSIMAGE
Scientific title: Social Cognition in Ageing and in Frontotemporal Lobar Degeneration (Frontotemporal Dementia and Semantic Dementia): a Cognitive and Neuroimaging Study
Date of first enrolment: June 2013
Target sample size: 80
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01962064
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Julien Chavant
Address: 
Telephone: 231065495
Email: memoire-rechcerche.caen@inserm.fr
Affiliation: 
Name:     Vincent de La Sayette, MD
Address: 
Telephone:
Email:
Affiliation:  University Hospital, Caen
Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Frontotemporal Lobar Degeneration
Aging
Intervention(s)
Behavioral: Cognitive assessment
Other: Brain imaging examination MRI
Primary Outcome(s)
Social cognition scores [Time Frame: 2 years]
Secondary Outcome(s)
Secondary ID(s)
2011-A00681-40
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Institut National de la Santé Et de la Recherche Médicale, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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