Amyotrophic Lateral SclerosisTBCSNCT06337578
Advances in Telephone-based Cognitive Screening Procedures
An observational study of Amyotrophic Lateral Sclerosis and Alzheimer's Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
1. Background Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Alzheimer's Disease, Lewy Body Dementia
- What is being tested?
- Telephone-based neuropsychological assessment - ALS, Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD and Telephone-based and in-person cognitive screening - NIs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- 1 siteItaly
- Study dates
- 25 Oct 2023to 25 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ALS: individuals having received a clinical diagnosis of ALS according to current diagnostic criteria AD: individuals with mild cognitive impairment/dementia due to either clinically- or neurochemically-confirmed Alzheimer's disease according to current diagnostic criteria LBD: individuals having received a clinical diagnosis of LBD according to current diagnostic criteria FTD: individuals having received a clinical diagnosis of FTD according to current diagnostic criteria CVD: individuals with mild cognitive impairment/dementia due to neuroradiologically-confirmed chronic cerebrovascular disease
Who may be able to join
- Patient cohorts: diagnosis of interest. NIs: not applicable
Who cannot join
- Patient cohorts
- age <18 years;
- denial of informed consent to voluntary participation and data processing;
- absence of the diagnosis of interest;
- absence of a de visu cognitive screening assessment carried out in the 6 months prior to recruitment;
- positive history of 1) psychiatric pathologies, 2) serious and/or uncompensated general-medical conditions and 3) uncorrected visual/hearing deficits.
Show all 10Show fewer
- NIs:
- age <18 years;
- denial of informed consent to voluntary participation and data processing;
- positive history of 1) brain disorders, 2) serious and/or uncompensated general-medical conditions and 3) uncorrected visual/hearing deficits.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, 20149
Barbara Poletti, Ph.D., +390261911 ext. 2609, b.poletti@auxologico.it
About this study
Official title: Avanzamenti in Materia di Screening Cognitivo Telefonico
- Background Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture). The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.
- Aims The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS.
- Methods
The study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA.
- Conditions
- Amyotrophic Lateral Sclerosis, Alzheimer's Disease, Lewy Body Dementia, Frontotemporal Degeneration, Cerebrovascular Disorders
- Being tested
- Telephone-based neuropsychological assessment - ALS, Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD, Telephone-based and in-person cognitive screening - NIs
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Alzheimer Disease, Lewy Body Disease, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based neuropsychological assessment - ALSBehavioural
ALS patients will be administered the following TBCS tests:
- ALS Cognitive Behavioral Screen-Phone Version;
- Telephone-based Frontal Assessment Battery;
- Telephone Language Screener;
- Telephone-based Verbal Fluency Battery;
This group will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:
- Activities of Daily Living;
- Instrumental Activities of Daily Living;
- Amsterdam IADL Questionnaire - Short Version;
- Caregiver Behavioral Questionnaire;
- ECAS-Carer Interview.
Telephone-based neuropsychological assessment - AD, LBD, FTD and CVDBehavioural
AD, DLB, FTD and CVD patients will be administered the following TBCS tests:
- Telephone Interview for Cognitive Status;
- Telephone-based Frontal Assessment Battery;
- Telephone Language Screener;
- Telephone-based Verbal Fluency Battery;
These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales:
- Activities of Daily Living;
- Instrumental Activities of Daily Living;
- Amsterdam IADL Questionnaire - Short Version;
- Neuropsychiatric Inventory;
- Frontal Behavioural Inventory.
Telephone-based and in-person cognitive screening - NIsBehavioural
NIs will undergo the Telephone Interview for Cognitive Status over the telephone and will be additionally administered, in person, the following cognitive screeners:
- Mini-Mental State Examination
- Montreal Cognitive Assessment
- In-Person Telephone Interview for Cognitive Status in person.
| Study group | Role | What they receive |
|---|---|---|
| Patients with amyotrophic lateral sclerosis (ALS) | Individuals having been received a clinical diagnosis of amyotrophic lateral sclerosis according to current diagnostic criteria Receives: Behavioral: Telephone-based neuropsychological assessment - ALS | |
| Patients with Alzheimer's disease (AD) | Individuals having been received a neurochemical and/or aclinical diagnosis of Alzheimer's according to current diagnostic criteria Receives: Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD | |
| Patients with Lewy body dementia (LBD) | Individuals having been received a clinical diagnosis of Lewy body dementia according to current diagnostic criteria Receives: Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD | |
| Patients with frontotemporal dementia (FTD) | Individuals having been received a clinical diagnosis of frontotemporal dementia (i.e., behavioural variant-frontotemporal dementia; semantic dementia; progressive non-fluent aphasia) according to current diagnostic criteria Receives: Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD | |
| Patients with chronic cerebrovascular disorders (CVD) | Individuals with mild cognitive impairment/dementia and neuroradiological evidence of chronic cerebrovascular diseases Receives: Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD | |
| Normotypical individuals (NI) | Individuals without brain disorders Receives: Behavioral: Telephone-based and in-person cognitive screening - NIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS Cognitive Behavioral Screen-Phone Version in ALS patients
ALS Cognitive Behavioral Screen-Phone Version
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients
Telephone Interview for Cognitive Status
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients
Telephone-based Frontal Assessment Battery
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients
Telephone Language Screener
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients
Telephone-based Verbal Fluency Battery
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Mini-Mental State Examination in NI
Mini-Mental State Examination; test with minimum score of 0 and maximum score of 30
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Montreal Cognitive Assessment in NI
Montreal Cognitive Assessment; test with maximum score of 30: score of 26 or more is considered normal
Measured: At enrollment and at 6 months, 12 months and 18 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start25 Oct 2023
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337578
- Sponsor's protocol ID
- 23C308
- Acronym
- TBCS
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avanzamenti in Materia di Screening Cognitivo Telefonico
- ClinicalTrials.gov ID
- NCT06337578
- Acronym / sponsor ID
- TBCS / 23C308
- Conditions
- Amyotrophic Lateral Sclerosis, Alzheimer's Disease, Lewy Body Dementia, Frontotemporal Degeneration, Cerebrovascular Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 29 Mar 2024 (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.
- Background Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture). The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.
- Aims The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS.
- Methods
The study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with amyotrophic lateral sclerosis (ALS) | – | Behavioral: Telephone-based neuropsychological assessment - ALSIndividuals having been received a clinical diagnosis of amyotrophic lateral sclerosis according to current diagnostic criteria |
| Patients with Alzheimer's disease (AD) | – | Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVDIndividuals having been received a neurochemical and/or aclinical diagnosis of Alzheimer's according to current diagnostic criteria |
| Patients with Lewy body dementia (LBD) | – | Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVDIndividuals having been received a clinical diagnosis of Lewy body dementia according to current diagnostic criteria |
| Patients with frontotemporal dementia (FTD) | – | Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVDIndividuals having been received a clinical diagnosis of frontotemporal dementia (i.e., behavioural variant-frontotemporal dementia; semantic dementia; progressive non-fluent aphasia) according to current diagnostic criteria |
| Patients with chronic cerebrovascular disorders (CVD) | – | Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVDIndividuals with mild cognitive impairment/dementia and neuroradiological evidence of chronic cerebrovascular diseases |
| Normotypical individuals (NI) | – | Behavioral: Telephone-based and in-person cognitive screening - NIsIndividuals without brain disorders |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALS: individuals having received a clinical diagnosis of ALS according to current diagnostic criteria AD: individuals with mild cognitive impairment/dementia due to either clinically- or neurochemically-confirmed Alzheimer's disease according to current diagnostic criteria LBD: individuals having received a clinical diagnosis of LBD according to current diagnostic criteria FTD: individuals having received a clinical diagnosis of FTD according to current diagnostic criteria CVD: individuals with mild cognitive impairment/dementia due to neuroradiologically-confirmed chronic cerebrovascular disease
Key inclusion criteria (1 listed)
- Patient cohorts: diagnosis of interest. NIs: not applicable
Key exclusion criteria (10 listed)
- Patient cohorts
- age <18 years;
- denial of informed consent to voluntary participation and data processing;
- absence of the diagnosis of interest;
- absence of a de visu cognitive screening assessment carried out in the 6 months prior to recruitment;
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 |
|---|---|---|
| Telephone-based neuropsychological assessment - ALSALS patients will be administered the following TBCS tests: * ALS Cognitive Behavioral Screen-Phone Version; * Telephone-based Frontal Assessment Battery; * Telephone Language Screener; * Telephone-based Verbal Fluency Battery; This group will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales: * Activities of Daily Living; * Instrumental Activities of Daily Living; * Amsterdam IADL Questionnaire - Short Version; * Caregiver Behavioral Questionnaire; * ECAS-Carer Interview. | Behavioural | Patients with amyotrophic lateral sclerosis (ALS) |
| Telephone-based neuropsychological assessment - AD, LBD, FTD and CVDAD, DLB, FTD and CVD patients will be administered the following TBCS tests: * Telephone Interview for Cognitive Status; * Telephone-based Frontal Assessment Battery; * Telephone Language Screener; * Telephone-based Verbal Fluency Battery; These groups will also undergo a telephone-based, caregiver-reported behavioral and functional assessment via the following scales: * Activities of Daily Living; * Instrumental Activities of Daily Living; * Amsterdam IADL Questionnaire - Short Version; * Neuropsychiatric Inventory; * Frontal Behavioural Inventory. | Behavioural | Patients with Alzheimer's disease (AD), Patients with Lewy body dementia (LBD), Patients with chronic cerebrovascular disorders (CVD), Patients with frontotemporal dementia (FTD) |
| Telephone-based and in-person cognitive screening - NIsNIs will undergo the Telephone Interview for Cognitive Status over the telephone and will be additionally administered, in person, the following cognitive screeners: * Mini-Mental State Examination * Montreal Cognitive Assessment * In-Person Telephone Interview for Cognitive Status in person. | Behavioural | Normotypical individuals (NI) |
Primary outcome
ALS Cognitive Behavioral Screen-Phone Version in ALS patients
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
ALS Cognitive Behavioral Screen-Phone Version
Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone Interview for Cognitive Status
Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone-based Frontal Assessment Battery
Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone Language Screener
Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
Telephone-based Verbal Fluency Battery
Mini-Mental State Examination in NI
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
Mini-Mental State Examination; test with minimum score of 0 and maximum score of 30
Montreal Cognitive Assessment in NI
Time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up
Montreal Cognitive Assessment; test with maximum score of 30: score of 26 or more is considered normal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Active, not recruitingObservational study
PREVENT ALL ALS Study
Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
RecruitingObservational study
Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis
Amyotrophic Lateral Sclerosis
Recruiting
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis)
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.
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 Alzheimer's Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Poletti, Ph.D. (+390261911 ext. 2609, b.poletti@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Cognitive Behavioral Screen-Phone Version in ALS patients (time frame: At enrollment and at 6 months, 12 months and 18 months of follow-up). The study lists 7 primary outcomes in all. 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 29 Mar 2024.