Advances in Telephone-based Cognitive Screening Procedures

NCT06337578 | Recruiting

• 1 other identifier: 23C308
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Background
2. 2.Aims
3. 3.Methods

Conditions

Amyotrophic Lateral Sclerosis; Alzheimer's Disease; Lewy Body Dementia; Frontotemporal Degeneration; Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (6)

Patients with amyotrophic lateral sclerosis (ALS)

Individuals having been received a clinical diagnosis of amyotrophic lateral sclerosis according to current diagnostic criteria

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

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

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

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

Behavioral: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD

Normotypical individuals (NI)

Individuals without brain disorders

Behavioral: Telephone-based and in-person cognitive screening - NIs

Interventions

Telephone-based neuropsychological assessment - ALS BEHAVIORAL

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.

Patients with amyotrophic lateral sclerosis (ALS)

Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD BEHAVIORAL

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.

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 - NIs BEHAVIORAL

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.

Normotypical individuals (NI)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Patient cohorts: diagnosis of interest. NIs: not applicable

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Alzheimer Disease; Lewy Body Disease; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Dementia; Brain Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Barbara Poletti, Ph.D.

CONTACT

+390261911; b.poletti@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: October 25, 2023
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

IT (1)