- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02819700
Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI) (ISDC)
July 17, 2020 updated by: Centre Hospitalier Universitaire, Amiens
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
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Strasbourg, France, 67091
- CHU Strasbourg
-
-
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 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ISDC (Behavioural Dysexecutive Syndrome Inventory)
Time Frame: Day 0
|
Behavioural Dysexecutive Syndrome Inventory
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 29, 2013
Primary Completion (Actual)
January 28, 2018
Study Completion (Actual)
January 28, 2018
Study Registration Dates
First Submitted
June 24, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (Estimate)
June 30, 2016
Study Record Updates
Last Update Posted (Actual)
July 20, 2020
Last Update Submitted That Met QC Criteria
July 17, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Heredodegenerative Disorders, Nervous System
- Tauopathies
- Cognition Disorders
- Language Disorders
- Communication Disorders
- Intracranial Arterial Diseases
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Chorea
- Aphasia
- Dementia
- Alzheimer Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Dementia, Vascular
- Huntington Disease
Other Study ID Numbers
- PI11-PR-GODEFROY-2
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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