Amyotrophic Lateral SclerosisNCT03578796
Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen in Norway: A Prospective Cohort Study
An observational study of Amyotrophic Lateral Sclerosis and Cognitive Impairment, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Cognitive Impairment
- What is being tested?
- ECAS-N, MoCA and CDR
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2017to 5 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who fullfill the inclusion criteria and attending to the ALS-clinic at HUH within 4 months after being diagnosed with ALS.
Who may be able to join
- Voluntary informed consent
- Native Norwegian speaker
Who cannot join
- Great difficulties in writing or reading
- Comorbid medical history
- Neurological disorders others than ALS
- Psychiatric history of importance to cognitive function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis
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.
Read the detailed description
Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Screening of cognitive and behavioral impairment is a distinct recommendation in ALS-specific health care. However, knowledge in how cognitive impairment shall influence health-care professionals' information given to patients and in decision making is lacking.
One of the major challenges in ALS management is the decision-making on advanced therapy. There is a lack of knowledge in how cognitive impairment in ALS shall be interfere on complex medical treatment that will affect quality of life or life itself. This means significant implications not only to the ALS patient and the community, but also the family and especially the spouse. Thus, further investigation of the ECAS-N and its potential in clinical use is needed. The scale may contribute a more proactive treatment better tailored to individual needs. The objective is to evaluate if the ECAS-N can be applied as an early predictor in car-driving, working and use of advanced life-prolonging therapy
- Being tested
- ECAS-N, MoCA, CDR, Questionnaire
- Keywords
- Amyotrophic Lateral Sclerosis, Cognitive, Predictor
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECAS-NDiagnostic test
Also called Edinburgh cognitive and behavioural ALS screen
assessing ALS-specific cognitive impairment
MoCADiagnostic test
Also called Montreal cognitive assessment
assessing cognitive impairment
CDRDiagnostic test
Also called Clinical dementia rating
assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia
QuestionnaireOther
Questions related to work situation and car driving
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ECAS-N; Diagnostic Test: MoCA; Diagnostic Test: CDR; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (11)
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.
Measured: 4 months
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.
Measured: 3 years or until death
Ability in car-driving
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 8 months
Ability in car-driving
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 4 months
Ability in car-driving
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 3 years or until death
Working ability
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 8 months
Working ability
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 4 months
Working ability
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 3 years or until death
Use of Advanced life-prolonging therapy
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 8 months
Use of Advanced life-prolonging therapy
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 4 months
Use of Advanced life-prolonging therapy
We will use a categorical variable (yes or no) and time of change to reduced function.
Measured: 3 years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 May 2017
- Primary completion31 Dec 2022
- Study completion5 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Western Norway University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Tina Taule, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578796
- Sponsor's protocol ID
- 2016/2187-1
- Status last verified
- Oct 2024
- First submitted
- 1 Jun 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in ALS: Screening Tools, Experiences and Prognosis
- ClinicalTrials.gov ID
- NCT03578796
- Acronym / sponsor ID
- 2016/2187-1
- Keywords
- Amyotrophic Lateral Sclerosis, Cognitive, Predictor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Western Norway University of Applied Sciences
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive impairment is present in about 30-50% of the patients with amyotrophic lateral sclerosis (ALS). Screening of cognitive and behavioral impairment is a distinct recommendation in ALS-specific health care. However, knowledge in how cognitive impairment shall influence health-care professionals' information given to patients and in decision making is lacking.
One of the major challenges in ALS management is the decision-making on advanced therapy. There is a lack of knowledge in how cognitive impairment in ALS shall be interfere on complex medical treatment that will affect quality of life or life itself. This means significant implications not only to the ALS patient and the community, but also the family and especially the spouse. Thus, further investigation of the ECAS-N and its potential in clinical use is needed. The scale may contribute a more proactive treatment better tailored to individual needs. The objective is to evaluate if the ECAS-N can be applied as an early predictor in car-driving, working and use of advanced life-prolonging therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with ALS | – | Diagnostic Test: ECAS-N, Diagnostic Test: MoCA, Diagnostic Test: CDR, Other: QuestionnairePersons 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who fullfill the inclusion criteria and attending to the ALS-clinic at HUH within 4 months after being diagnosed with ALS.
Key inclusion criteria (2 listed)
- Voluntary informed consent
- Native Norwegian speaker
Key exclusion criteria (4 listed)
- Great difficulties in writing or reading
- Comorbid medical history
- Neurological disorders others than ALS
- Psychiatric history of importance to cognitive function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECAS-NAlso: Edinburgh cognitive and behavioural ALS screenassessing ALS-specific cognitive impairment | Diagnostic test | Persons with ALS |
| MoCAAlso: Montreal cognitive assessmentassessing cognitive impairment | Diagnostic test | Persons with ALS |
| CDRAlso: Clinical dementia ratingassessing global cognitive impairment, as well as possible diagnosis- and Level of dementia | Diagnostic test | Persons with ALS |
| QuestionnaireQuestions related to work situation and car driving | Other | Persons with ALS |
Primary outcome
Clinical Dementia Rating (CDR)
Time frame: 8 months
We will use the total CDR score (minimum score = 0, maximum score = 18). Low scores indicate less problems than high scores.
11 secondary outcomes
Clinical Dementia Rating (CDR)
Time frame: 4 months
Clinical Dementia Rating (CDR)
Time frame: 3 years or until death
Ability in car-driving
Time frame: 8 months
Ability in car-driving
Time frame: 4 months
Ability in car-driving
Time frame: 3 years or until death
Working ability
Time frame: 8 months
Working ability
Time frame: 4 months
Working ability
Time frame: 3 years or until death
Use of Advanced life-prolonging therapy
Time frame: 8 months
Use of Advanced life-prolonging therapy
Time frame: 4 months
Use of Advanced life-prolonging therapy
Time frame: 3 years or until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Taule, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Cognitive Impairment, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Dementia Rating (CDR) (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.