Advances in Telephone-based Cognitive Screening Procedures

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Alzheimer's Disease; Lewy Body Dementia; Cerebrovascular Disorders; Frontotemporal Degeneration
• Interventions: Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD; Behavioral: Telephone-based neuropsychological assessment - ALS; Behavioral: Telephone-based and in-person cognitive screening - NIs

• Registration Number: NCT06337578
• Lead Sponsor: Istituto Auxologico Italiano

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-25
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Primary Completion: 2026-10-25
• Study Completion: 2026-10-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Lewy body dementia (LBD)	Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD	Individuals having been received a clinical diagnosis of Lewy body dementia according to current diagnostic criteria
Patients with chronic cerebrovascular disorders (CVD)	Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD	Individuals with mild cognitive impairment/dementia and neuroradiological evidence of chronic cerebrovascular diseases
Patients with amyotrophic lateral sclerosis (ALS)	Telephone-based neuropsychological assessment - ALS	Individuals having been received a clinical diagnosis of amyotrophic lateral sclerosis according to current diagnostic criteria
Patients with Alzheimer's disease (AD)	Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD	Individuals having been received a neurochemical and/or aclinical diagnosis of Alzheimer's according to current diagnostic criteria
Patients with frontotemporal dementia (FTD)	Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD	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
Normotypical individuals (NI)	Telephone-based and in-person cognitive screening - NIs	Individuals without brain disorders

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Examination in NI	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
ALS Cognitive Behavioral Screen-Phone Version in ALS patients	At enrollment and at 6 months, 12 months and 18 months of follow-up	ALS Cognitive Behavioral Screen-Phone Version
Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients	At enrollment and at 6 months, 12 months and 18 months of follow-up	Telephone-based Verbal Fluency Battery
Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients	At enrollment and at 6 months, 12 months and 18 months of follow-up	Telephone Interview for Cognitive Status
Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients	At enrollment and at 6 months, 12 months and 18 months of follow-up	Telephone Language Screener
Montreal Cognitive Assessment in NI	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
Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients	At enrollment and at 6 months, 12 months and 18 months of follow-up	Telephone-based Frontal Assessment Battery

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milano, Italy