NCT03579017

Brief Summary

Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Suitable screening tools are available, but none of these are evaluated in a Norwegian population.

Trial Health

87
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
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

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 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2023

Completed
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 sclerosisCognitiveScreeningValidation

Outcome Measures

Primary Outcomes (1)

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

    We will use the ALS-specific sub-score (minimum score = 0, maximum score = 100), the ALS non-specific sub-score (minimum score = 0, maximum score = 36), a summed total ECAS-N score (minimum score =0, maximum score =136), the sub score of behavioural changes (minimum score = 0, maximum score = 10) and the sub score of psychotic change (minimum score = 0, maximum score = 3). A dichotomized cut-off scores for normality will also be used for the ALS-specific cut-off score of 65 or over, the non ALS-specific cut-off score of 24 or over and the total ECAS-N cut-off score of 92 or over. For the ALS-specific scores, non ALS-specific scores and total ECAS-N scores, high scores indicate less problems than low scores. For the sub score of behavioural change and the sub score of psychotic change, high scores indicate more problems than low scores.

    4 months

Secondary Outcomes (2)

  • Montreal cognitive assessment (MoCA) - Norwegian version

    4 months

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

    8 months

Study Arms (3)

Patients with ALS

Patients with ALS will be tested by two independent testers with the ECAS-N at 4 months (baseline) and 8 months (follow-up), and the MoCA at 4 months (baseline) by one tester

Diagnostic Test: ECAS-NDiagnostic Test: MoCA

Healthy controls

Persons with no cognitive impairment will be tested with the ECAS-N once, by one tester

Diagnostic Test: ECAS-N

Controls with dementia

Persons with cognitive impairment due to other disorders will be tested with the ECAS-N once, by one tester

Diagnostic Test: ECAS-N

Interventions

ECAS-NDIAGNOSTIC_TEST

All participants included will be tested with the ECAS-N

Also known as: Edinburgh cognitive and behavioral ALS screen (Norwegian)
Controls with dementiaHealthy controlsPatients with ALS
MoCADIAGNOSTIC_TEST

All included patients With ALS will be tested With the MoCA

Also known as: Montreal cognitive assessment (MoCA)
Patients with ALS

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who fulfill the inclution criteria and attending to the ALS-unit at HUH, St.Olavs Hospital, Hospital of Southern Norway or Namsos Hospital, within 4 months after being diagnosed With ALS. Healthy People and patients with dementia will constitute Control groups

You may qualify if:

  • voluntary informed consent
  • native Norwegian speaker
  • aged between 35 and 85 years old (only for Controls)

You may not qualify if:

  • great difficulties in writing og 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

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

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

May 4, 2023

Last Updated

October 30, 2024

Record last verified: 2024-10

Locations

NO(1)