NCT03578796

Brief Summary

This study evaluate use of a translated Norwegian version of the Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen (ECAS-N) as an early predictor in car-driving, working and use of advanced life-prolonging therapy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
May 2017Dec 2026

Study Start

First participant enrolled

May 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 30, 2024

Status Verified

October 1, 2024

Enrollment Period

5.7 years

First QC Date

June 1, 2018

Last Update Submit

October 28, 2024

Conditions

Amyotrophic Lateral SclerosisCognitive Impairment

Keywords

Amyotrophic Lateral SclerosisCognitivePredictor

Outcome Measures

Primary Outcomes (1)

  • Clinical Dementia Rating (CDR)

    We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.

    8 months

Secondary Outcomes (11)

  • Clinical Dementia Rating (CDR)

    4 months

  • Clinical Dementia Rating (CDR)

    3 years or until death

  • Ability in car-driving

    8 months

  • Ability in car-driving

    4 months

  • Ability in car-driving

    3 years or until death

  • +6 more secondary outcomes

Other Outcomes (4)

  • Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N)

    4 months

  • Change from 4 months Edinburgh cognitive and behavioral amyotrophic lateral sclerosis screen-Norwegian Version (ECAS-N) at 8 months

    8 months

  • Montreal Cognitive Assessment (MoCA)

    4 months

  • +1 more other outcomes

Study Arms (1)

Persons with ALS

Persons With possible ALS-specific cognitive impairment will be tested With ECAS-N, MoCA, CDR and a questionnaire at 4 months (baseline) and 8 months (1. follow-up). Further evaluation will be with the questionnaire and CDR at each follow-up until 3 years or use of permanent ventilation support or Death. Information about use of advanced life-prolonging therapy will be collected from patient journal.

Diagnostic Test: ECAS-NDiagnostic Test: MoCADiagnostic Test: CDROther: Questionnaire

Interventions

ECAS-NDIAGNOSTIC_TEST

assessing ALS-specific cognitive impairment

Also known as: Edinburgh cognitive and behavioural ALS screen
Persons with ALS
MoCADIAGNOSTIC_TEST

assessing cognitive impairment

Also known as: Montreal cognitive assessment
Persons with ALS
CDRDIAGNOSTIC_TEST

assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia

Also known as: Clinical dementia rating
Persons with ALS
QuestionnaireOTHER

Questions related to work situation and car driving

Persons with ALS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who fullfill the inclusion criteria and attending to the ALS-clinic at HUH within 4 months after being diagnosed with ALS.

You may qualify if:

  • Voluntary informed consent
  • Native Norwegian speaker

You may not qualify if:

  • Great difficulties in writing or reading
  • Comorbid medical history
  • Neurological disorders others than ALS
  • Psychiatric history of importance to cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisCognitive Dysfunction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tina Taule, PhD

    Haukeland University Hospital

    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 1, 2018

First Posted

July 6, 2018

Study Start

May 1, 2017

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

October 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)