Frontotemporal Lobar DegenerationCOSIMAGENCT01962064
Social Cognition in Ageing and in Frontotemporal Lobar Degeneration
A study testing Cognitive assessment and Brain imaging examination MRI in people with Frontotemporal Lobar Degeneration and Aging, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Lobar Degeneration, Aging
- What is being tested?
- Cognitive assessment and Brain imaging examination MRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Inserm - EPHE - University of Caen U1077
Caen, 14000
About this study
Official title: 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.
- Conditions
- Frontotemporal Lobar Degeneration, Aging
- Being tested
- Cognitive assessment, Brain imaging examination MRI
- Medical subject headings
- Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentBehavioural
Brain imaging examination MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Semantic demantia | Experimental | cognitive assessment and Brain imaging examination MRI of patient with the semantic variant of primary progressive aphasia Receives: Behavioral: Cognitive assessment; Other: Brain imaging examination MRI |
| Frontotemporal dementia | Experimental | cognitive assessment and Brain imaging examination MRI of patients with the behavioral variant of frontotemporal lobar degeneration Receives: Behavioral: Cognitive assessment; Other: Brain imaging examination MRI |
| Elderly | Experimental | cognitive assessment and Brain imaging examination MRI of healthy elderly subjects Receives: Behavioral: Cognitive assessment; Other: Brain imaging examination MRI |
| Young | Experimental | cognitive assessment and Brain imaging examination MRI of young subjects Receives: Behavioral: Cognitive assessment; Other: Brain imaging examination MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social cognition scores
number of correct responses in a social cognition test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal Lobar DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent de La Sayette, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962064
- Sponsor's protocol ID
- 2011-A00681-40
- Acronym
- COSIMAGE
- Status last verified
- Oct 2013
- First submitted
- 3 Sep 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition in Ageing and in Frontotemporal Lobar Degeneration (Frontotemporal Dementia and Semantic Dementia): a Cognitive and Neuroimaging Study
- ClinicalTrials.gov ID
- NCT01962064
- Acronym / sponsor ID
- COSIMAGE / 2011-A00681-40
- Conditions
- Frontotemporal Lobar Degeneration, Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Semantic demantia | Experimental | Behavioral: Cognitive assessment, Other: Brain imaging examination MRIcognitive assessment and Brain imaging examination MRI of patient with the semantic variant of primary progressive aphasia |
| Frontotemporal dementia | Experimental | Behavioral: Cognitive assessment, Other: Brain imaging examination MRIcognitive assessment and Brain imaging examination MRI of patients with the behavioral variant of frontotemporal lobar degeneration |
| Elderly | Experimental | Behavioral: Cognitive assessment, Other: Brain imaging examination MRIcognitive assessment and Brain imaging examination MRI of healthy elderly subjects |
| Young | Experimental | Behavioral: Cognitive assessment, Other: Brain imaging examination MRIcognitive assessment and Brain imaging examination MRI of young subjects |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All the participants
- Healthy subjects
- Patients
Key exclusion criteria (9 listed)
- Chronic neurological disease
- Encephalitis
- Endocrinal disease
- Hepatic disease
- Case history of head injury with loss of consciousness of more than one hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assessment | Behavioural | Elderly, Frontotemporal dementia, Semantic demantia, Young |
| Brain imaging examination MRI | Other | Elderly, Frontotemporal dementia, Semantic demantia, Young |
Primary outcome
Social cognition scores
Time frame: 2 years
number of correct responses in a social cognition test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent de La Sayette, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive assessment and Brain imaging examination MRI in people with Frontotemporal Lobar Degeneration and Aging, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Chavant (231065495 ext. +33, memoire-rechcerche.caen@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social cognition scores (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.