Actively Recruiting

Age: 60Years +
All Genders
Healthy Volunteers
ID06701630

Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment, and Mild Dementia

Led by Casa di Cura IGEA · Updated on 2025-02-13

390

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an observational study to translate, adapt, and validate several functional and behavioral scales used for diagnosing neurodegenerative diseases in Italian, where formal versions are currently unavailable. The study focuses on scales assessing daily living activities and behavioral symptoms, including Katz's index, Lawton and Brody's scale, Everyday Cognition questionnaire (E-Cog), Neuropsychiatric Inventory Questionnaire (NPI-Q), and a modified Functional Activities Questionnaire (M-FAQ). The study also aims to evaluate the reliability and validity of these tools and to establish cut-off scores to distinguish between neurologically unimpaired elderly, subjective cognitive decline (SCD), mild cognitive impairment (MCI), and mild Alzheimer's disease (AD).

CONDITIONS

Brief Title

Italian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia.

Who Can Participate

Age: 60Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Availability of an informant or caregiver able to judge functional abilities
  • Normal performance on the Mini Mental State Examination for neurologically unimpaired elderly participants
  • Diagnosis consistent with Subjective Cognitive Decline for SCD group
  • Diagnosis consistent with Mild Cognitive Impairment for MCI group
  • Diagnosis consistent with Mild Major Neurocognitive Disorder according to DSM-5-TR for mild dementia group
Not Eligible

You will not qualify if you...

  • Refusal or inability to sign informed consent
  • Presence of other neurological or psychiatric conditions that may explain cognitive difficulties for clinical groups

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants and their caregivers/informants provide demographic and clinical information, and undergo administration of functional rating scales and questionnaires to assess cognitive and behavioral status.

1 visit (in-person)

Long-term Monitoring

Duration - Up to the end of study completion (November 2026)

Participants are observed over time to validate the functional and behavioral scales and monitor cognitive and behavioral changes.

Assessments occur during study period as needed

Trial Site Locations

Total: 1 location

1

Casa di Cura Igea

Milan, Michigan, Italy

Actively Recruiting

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Research Team

S

Sabrina Guzzetti, Psychologist

L

Laura Veronelli, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Frequently Asked Questions

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Published Research Related To This Trial

Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment.

B Winblad, K Palmer, M Kivipelto...

https://pubmed.ncbi.nlm.nih.gov/15324367

The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.

Guy M McKhann, David S Knopman, Howard Chertkow...

https://pubmed.ncbi.nlm.nih.gov/21514250