Advances in Telephone-based Cognitive Screening Procedures

Alzheimer's Disease Clinical Trial

— TBCS  

Official title:

Avanzamenti in Materia di Screening Cognitivo Telefonico

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337578
• Other study ID #: 23C308
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: October 25, 2026

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Barbara Poletti, Ph.D.
• Phone: +390261911
• Email: b.poletti[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: October 25, 2026
• Est. primary completion date: October 25, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion criteria:

Patient cohorts: diagnosis of interest. NIs: not applicable

Exclusion Criteria:

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.

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Amyotrophic Lateral Sclerosis
• Cerebrovascular Disorders
• Frontotemporal Degeneration
• Lewy Body Dementia
• Lewy Body Disease
• Motor Neuron Disease

Intervention

Behavioral:
• Telephone-based neuropsychological assessment - ALS
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 CVD
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 - NIs
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.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALS Cognitive Behavioral Screen-Phone Version in ALS patients	ALS Cognitive Behavioral Screen-Phone Version	At enrollment and at 6 months, 12 months and 18 months of follow-up
Primary	Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients	Telephone Interview for Cognitive Status	At enrollment and at 6 months, 12 months and 18 months of follow-up
Primary	Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients	Telephone-based Frontal Assessment Battery	At enrollment and at 6 months, 12 months and 18 months of follow-up
Primary	Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients	Telephone Language Screener	At enrollment and at 6 months, 12 months and 18 months of follow-up
Primary	Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients	Telephone-based Verbal Fluency Battery	At enrollment and at 6 months, 12 months and 18 months of follow-up
Primary	Mini-Mental State Examination in NI	Mini-Mental State Examination; test with minimum score of 0 and maximum score of 30	At enrollment and at 6 months, 12 months and 18 months of follow-up
Primary	Montreal Cognitive Assessment in NI	Montreal Cognitive Assessment; test with maximum score of 30: score of 26 or more is considered normal	At enrollment and at 6 months, 12 months and 18 months of follow-up