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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02819700
Other study ID # PI11-PR-GODEFROY-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 29, 2013
Est. completion date January 28, 2018

Study information

Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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), 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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date January 28, 2018
Est. primary completion date January 28, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility 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 Design


Intervention

Behavioral:
prevalence of behavioural dysexecutive syndrome
Behavioural Dysexecutive Syndrome Inventory (ISDC)

Locations

Country Name City State
France CHU Amiens Amiens
France CHU Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary ISDC (Behavioural Dysexecutive Syndrome Inventory) Behavioural Dysexecutive Syndrome Inventory Day 0
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