Alzheimer DiseaseGREFEXIINCT03052712
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
A study testing social cognition in people with Alzheimer Disease and Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Parkinson Disease, Frontal Dementia
- What is being tested?
- social cognition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2016to 8 Sep 2019
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF)
- Male or female, aged 20 to 80 years inclusive at the time of signing ICF
- French-speaking
- reliable informant
- Controls:
- derived from the general population and consenting to participate in the study
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- Patients:
- MMS>18
- Patients followed for mild or major neurocognitive disorder related to :
- Alzheimer's disease
- Frontotemporal lobar degeneration
- Lewy bodies disease
- Parkinson's disease
- Huntington's disease
- Progressive supranuclear palsy
- traumatic brain injury
- stroke or cerebral anoxia
- mixed diseases
- focal cerebral diseases
Who cannot join
- Illiteracy
- mental retardation
- visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0)
- hearing impairment interfering with understanding of instructions,
- history of brain disease, including head injury with loss of consciousness lasting > 15 minutes, stroke, coma or loss of consciousness lasting > 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment
- history of psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (major depressive disorder or other condition) currently requiring treatment or requiring a stay > 2 days in a psychiatry unit or anxiety requiring more than one medication at the present time
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- alcoholism (mean alcohol consumption > 3 standard drinks/day or history of alcohol withdrawal)
- use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome
- ongoing antidepressant or antiepileptic treatment
- anxiolytic or hypnotic treatment initiated or increased during the previous month
- general anaesthesia during the previous 3 months
- history of heart surgery with cardiopulmonary bypass
- comorbidities affecting cognition (respiratory, renal, liver, heart failure…)
- women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)
- persons placed under judicial protection
- Patients :
- contraindication to MRI
- Controls:
- deficit on MMSE <27
Trial locations and contacts
1 site in 1 country.
About this study
The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.
- Conditions
- Alzheimer Disease, Parkinson Disease, Frontal Dementia, Huntington Disease, Traumatic Brain Injury, Stroke
- Being tested
- social cognition
- Keywords
- Disorders of socio-emotional, Alzheimer, frontal temporal dementia, Parkinson, Huntington, traumatic brain injury, stroke, focal lesions
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Huntington Disease, Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social cognitionBehavioural
battery of tests of social cognition
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | battery of tests of social cognition Receives: Behavioral: social cognition |
| Control | Active comparator | battery of tests of social cognition Receives: Behavioral: social cognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
tests of social cognition (questionnaire)
standardize and validate in French-speaking population a comprehensive battery of tests of social cognition
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start9 Sep 2016
- Primary completion8 Sep 2019
- Study completion8 Sep 2019
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GODEFROY, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052712
- Sponsor's protocol ID
- PI2015_843_0031
- Acronym
- GREFEXII
- Status last verified
- Oct 2019
- First submitted
- 7 Feb 2017
- Last updated
- 21 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
- ClinicalTrials.gov ID
- NCT03052712
- Acronym / sponsor ID
- GREFEXII / PI2015_843_0031
- Conditions
- Alzheimer Disease, Parkinson Disease, Frontal Dementia, Huntington Disease, Traumatic Brain Injury, Stroke
- Keywords
- Disorders of socio-emotional, Alzheimer, frontal temporal dementia, Parkinson, Huntington, traumatic brain injury, stroke, focal lesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Sep 2016 (actual)
- Primary completion
- 8 Sep 2019 (actual)
- Study completion
- 8 Sep 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- 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 role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Behavioral: social cognitionbattery of tests of social cognition |
| Control | Active comparator | Behavioral: social cognitionbattery of tests of social cognition |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Provision of signed and dated informed consent form (ICF)
- Male or female, aged 20 to 80 years inclusive at the time of signing ICF
- French-speaking
- reliable informant
- derived from the general population and consenting to participate in the study
Key exclusion criteria (19 listed)
- Illiteracy
- mental retardation
- visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0)
- hearing impairment interfering with understanding of instructions,
- history of brain disease, including head injury with loss of consciousness lasting > 15 minutes, stroke, coma or loss of consciousness lasting > 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment
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 |
|---|---|---|
| social cognitionbattery of tests of social cognition | Behavioural | Control, Patients |
Primary outcome
tests of social cognition (questionnaire)
Time frame: 3 years
standardize and validate in French-speaking population a comprehensive battery of tests of social cognition
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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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.
Olivier GODEFROY, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social cognition in people with Alzheimer Disease and Parkinson Disease, run by Centre Hospitalier Universitaire, Amiens 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 19 inclusion and 19 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: stopped early, as of the sponsor's last update on 21 Oct 2019. 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?
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tests of social cognition (questionnaire) (time frame: 3 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 21 Oct 2019.