NCT01530438

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that involves not only motor structures, as was previously thought, but also brain areas dealing with cognition as well as parts of the limbic system. Clinical, imaging and pathological evidence suggests that ALS and fronto-temporal dementia (FTD) have several features in common, and that these two diseases could be the two ends of a pathological continuum.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 years until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

April 9, 2014

Status Verified

March 1, 2014

Enrollment Period

5.7 years

First QC Date

February 22, 2010

Last Update Submit

April 8, 2014

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis

Outcome Measures

Primary Outcomes (1)

  • Cognitive, behavioural and emotional changes assesed with Neuropsychological tests.

    Between 9 and 12 mth

Secondary Outcomes (1)

  • brain imaging (anatomical MRI, functional MRI, PET using 18FDG)

    Between 9 and 12 mth

Study Arms (3)

ALS patients without cognitive disorders

OTHER

Amyotrophic lateral sclerosis without cognitive disorders

Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

ALS patients with cognitive disorders

OTHER

Amyotrophic lateral sclerosis with cognitive disorders

Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

ALS patients + frontal-temporal dementia

OTHER

Amyotrophic lateral sclerosis plus frontal-temporal dementia

Other: MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research

Interventions

MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the researchOTHER

At T0 and T9 or 12 monts, are performed : * Imaging : fMRI at rest and anatomical MRI * Neuropsychological assessments : general cognitive functioning, theory of mind, executive functions ...

ALS patients + frontal-temporal dementiaALS patients with cognitive disordersALS patients without cognitive disorders

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants :
  • study level \> 7 years
  • mother tongue : french
  • signature of the informed consent of the protocol in accord with the Comité de Protection des Personnes
  • Patients ALS :
  • to 80 years old
  • Diagnostic defined or probable in according to the reviewed criteria of El Escorial.
  • Patients ALS / FTD :
  • to 8O years old
  • Diagnostic defined or probable in according to El Escorial reviewed criteria and diagnostic of frontal-temporal dementia in according to Lund et Manchester criteria.
  • Control Subjects :
  • to 75 years old
  • DRS ≥ 130
  • BECK \< 8

You may not qualify if:

  • All particpants :
  • Major past history (chronic pulmonary disease, cardiac disease, metabolic, haematological, endocrinological or severe immunological, cancer) ;
  • Chronic use of alcohol or drugs ;
  • IRM contraindications
  • Patients SLA and patients SLA / FTD
  • Severe bulbar disorders
  • Severe restrictive respiratory insufficiency (VC\<50%) with orthopny
  • Communication disorders with motor origin (non assessable tests)
  • Control Subjects :
  • Pregnant or nursing women
  • Unability to submit at the study medical follow-up for geographic or psychiatric reasons(previous or ongoing).
  • DRS score \< 130
  • Depressive syndrome (BECK) ≥ 8

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Center

Caen, 14033, France

RECRUITING

University Hospital Center

Rouen, 76031, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Laurence Carluer, MD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 10, 2012

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

April 9, 2014

Record last verified: 2014-03

Locations

FR(2)