Frontotemporal DementiaISDCNCT02819700
Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI)
An observational study of Frontotemporal Dementia and Huntington Disease, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
Behavioural disorders are very common right from the initial stage of dementia and contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their prevalence and their diagnostic importance, as they often constitute the initial symptoms of Frontotemporal Dementia (FTD)… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Frontotemporal Dementia, Huntington Disease, Alzheimer Disease
- What is being tested?
- prevalence of behavioural dysexecutive syndrome
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jan 2013to 28 Jan 2018
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: French-speaking subjects between the ages of 40 and 85 years with an MMSE score > 15/30, followed for AD or MCI or VaD or FTD or SD or HD will be selected by their neurologist during a routine memory assessment visit.
Who may be able to join
- Support to the consultation memory for a neurological disease ( frontotemporal dementia , vascular dementia , Alzheimer's disease , mild cognitive disorder, Huntington's disease ( with genetic diagnosis confirmed : number of CAG triplets > 36 symptomatic : UHDRS score ≥5 ) with MMS > 15
- Age 40 to 85 years
- French
- Informing reliable
- Agreeing to participate in the study.
Who cannot join
- Presence of other disease disturbing behavior ( current depressive syndrome , schizophrenia, psychosis , past psychiatric disorders requiring a stay > 2 days in a specialized environment ) or cognition (mental retardation , illiteracy , respiratory failure, kidney , liver , heart ) or preventing the realization of the tests ( perceptual or motor deficit ) intrecérébrale pacing therapy or stem cell transplant , patient protected ( under supervision or guardianship ) , pregnant and / or breastfeeding and lack of consent
Trial locations and contacts
2 sites in 1 country.
About this study
Behavioural disorders are very common right from the initial stage of dementia and contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their prevalence and their diagnostic importance, as they often constitute the initial symptoms of Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD). The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been partially evaluated and would increase the risk of progression to dementia. These classical data are based on non-standardized assessments and non-validated diagnostic criteria. The Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a standardized assessment tool for behavioural dysexecutive disorders, the Behavioural Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this syndrome.
- Conditions
- Frontotemporal Dementia, Huntington Disease, Alzheimer Disease, Semantic Dementia, Dementia, Vascular
- Being tested
- prevalence of behavioural dysexecutive syndrome
- Keywords
- behavioural disorders
- Medical subject headings
- Frontotemporal Dementia, Huntington Disease, Alzheimer Disease, Dementia, Vascular, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevalence of behavioural dysexecutive syndromeBehavioural
Behavioural Dysexecutive Syndrome Inventory (ISDC)
What is being measured
The primary outcome is the main question the study is designed to answer.
ISDC (Behavioural Dysexecutive Syndrome Inventory)
Behavioural Dysexecutive Syndrome Inventory
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start29 Jan 2013
- Primary completion28 Jan 2018
- Study completion28 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 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
- NCT02819700
- Sponsor's protocol ID
- PI11-PR-GODEFROY-2
- Acronym
- ISDC
- Status last verified
- Jul 2020
- First submitted
- 24 Jun 2016
- Last updated
- 20 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI)
- ClinicalTrials.gov ID
- NCT02819700
- Acronym / sponsor ID
- ISDC / PI11-PR-GODEFROY-2
- Conditions
- Frontotemporal Dementia, Huntington Disease, Alzheimer Disease, Semantic Dementia, Dementia, Vascular
- Keywords
- behavioural disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 29 Jan 2013
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 30 Jun 2016 (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.
Behavioural disorders are very common right from the initial stage of dementia and contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their prevalence and their diagnostic importance, as they often constitute the initial symptoms of Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD). The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been partially evaluated and would increase the risk of progression to dementia. These classical data are based on non-standardized assessments and non-validated diagnostic criteria. The Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a standardized assessment tool for behavioural dysexecutive disorders, the Behavioural Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- French-speaking subjects between the ages of 40 and 85 years with an MMSE score > 15/30, followed for AD or MCI or VaD or FTD or SD or HD will be selected by their neurologist during a routine memory assessment visit.
Key inclusion criteria (5 listed)
- Support to the consultation memory for a neurological disease ( frontotemporal dementia , vascular dementia , Alzheimer's disease , mild cognitive disorder, Huntington's disease ( with genetic diagnosis confirmed : number of CAG triplets > 36 symptomatic : UHDRS score ≥5 ) with MMS > 15
- Age 40 to 85 years
- French
- Informing reliable
- Agreeing to participate in the study.
Key exclusion criteria (1 listed)
- Presence of other disease disturbing behavior ( current depressive syndrome , schizophrenia, psychosis , past psychiatric disorders requiring a stay > 2 days in a specialized environment ) or cognition (mental retardation , illiteracy , respiratory failure, kidney , liver , heart ) or preventing the realization of the tests ( perceptual or motor deficit ) intrecérébrale pacing therapy or stem cell transplant , patient protected ( under supervision or guardianship ) , pregnant and / or breastfeeding and lack of consent
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 |
|---|---|---|
| prevalence of behavioural dysexecutive syndromeBehavioural Dysexecutive Syndrome Inventory (ISDC) | Behavioural | – |
Primary outcome
ISDC (Behavioural Dysexecutive Syndrome Inventory)
Time frame: Day 0
Behavioural Dysexecutive Syndrome Inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
Related trials for Frontotemporal Dementia
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frontotemporal Dementia and Huntington Disease, run by Centre Hospitalier Universitaire, Amiens at 2 sites 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ISDC (Behavioural Dysexecutive Syndrome Inventory) (time frame: Day 0). 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 20 Jul 2020.