NCT02819700

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2018

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

5 years

First QC Date

June 24, 2016

Last Update Submit

July 17, 2020

Conditions

Keywords

behavioural disorders

Outcome Measures

Primary Outcomes (1)

  • ISDC (Behavioural Dysexecutive Syndrome Inventory)

    Behavioural Dysexecutive Syndrome Inventory

    Day 0

Interventions

Behavioural Dysexecutive Syndrome Inventory (ISDC)

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Amiens

Amiens, 80054, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Frontotemporal DementiaHuntington DiseaseAlzheimer DiseaseDementia, VascularMental Disorders

Condition Hierarchy (Ancestors)

Frontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersBasal Ganglia DiseasesChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersTauopathiesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier GODEFROY, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2016

First Posted

June 30, 2016

Study Start

January 29, 2013

Primary Completion

January 28, 2018

Study Completion

January 28, 2018

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations