NCT01962064

Brief Summary

The purpose of this study is to examine the age and the neurodegenerative disease effects on social cognition. Secondary goals are to better understand the relationships between different component of social cognition, executive functioning, and behavior and describing the neuronal substrates associated to the alteration of the social cognition in ageing and dementia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

September 3, 2013

Last Update Submit

October 10, 2013

Conditions

Frontotemporal Lobar DegenerationAging

Outcome Measures

Primary Outcomes (1)

  • Social cognition scores

    number of correct responses in a social cognition test

    2 years

Study Arms (4)

Semantic demantia

EXPERIMENTAL

cognitive assessment and Brain imaging examination MRI of patient with the semantic variant of primary progressive aphasia

Behavioral: Cognitive assessmentOther: Brain imaging examination MRI

Frontotemporal dementia

EXPERIMENTAL

cognitive assessment and Brain imaging examination MRI of patients with the behavioral variant of frontotemporal lobar degeneration

Behavioral: Cognitive assessmentOther: Brain imaging examination MRI

Elderly

EXPERIMENTAL

cognitive assessment and Brain imaging examination MRI of healthy elderly subjects

Behavioral: Cognitive assessmentOther: Brain imaging examination MRI

Young

EXPERIMENTAL

cognitive assessment and Brain imaging examination MRI of young subjects

Behavioral: Cognitive assessmentOther: Brain imaging examination MRI

Interventions

Cognitive assessmentBEHAVIORAL
ElderlyFrontotemporal dementiaSemantic demantiaYoung
Brain imaging examination MRIOTHER
ElderlyFrontotemporal dementiaSemantic demantiaYoung

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All the participants
  • Age between 40 and 80 years
  • Minimum of 7 years of education
  • French native speaker
  • Healthy subjects
  • Non pathological Dementia rating scale score
  • Patients
  • Clinical diagnosis of frontotemporal lobar degeneration

You may not qualify if:

  • Chronic neurological disease
  • Encephalitis
  • Endocrinal disease
  • Hepatic disease
  • Case history of head injury with loss of consciousness of more than one hour
  • Case history of stroke
  • Case history of cancer during the five last years except squamous cell carcinomas
  • Alcoholism or drug addiction
  • Major psychiatric disorders according the Diagnostic and Statistical Manual of Mental Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inserm - EPHE - University of Caen U1077

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Frontotemporal Lobar Degeneration

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Vincent de La Sayette, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Chavant

CONTACT

231065495memoire-rechcerche.caen@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

October 14, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

October 14, 2013

Record last verified: 2013-10

Locations

FR(1)