Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT05815329

MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2025-05-08

100

Participants Needed

1

Research Sites

230 weeks

Total Duration

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AI-Summary

What this Trial Is About

Subjective cognitive decline-SCD is a subclinical cognitive impairment subjectively experienced without being detectable from a diagnostic and neuropsychological perspective. It can negatively impact on patient's frailty and quality of life and it may be prodromal to severe cognitive impairment. Currently, only a few screening tools focusing mainly on memory complaints exist. The aim of this study is to analyze if a new screening tool called MASCoD (Multidimensional Assessment of Subjective Cognitive Decline) can detect and monitor the SCD, predicting the risk of developing severe cognitive decline over time. Specifically, the investigators have the following aims: primary objectives: 1. To assess the construct validity and tune the clinical cutoffs of the new instrument through the correlation of MASCoD scores with neuropsychological evaluation and brain 18F-FDG-PET. 2. To assess the clinical validity (predictive capability) of the new instrument through a classification model (dependent variable: brain 18F-FDG-PET examination; independent variable: MASCoD; control variables: gender, age and neuropsychological evaluation). Secondary objective: To evaluate the suitability of MASCoD as tool for the monitoring of patients over time. Specifically, the investigators want to evaluate if the MASCoD score is able to assess the effects of a cognitive treatment and, in turn, to identify outpatients who most likely will benefit from it. After the multidimensional evaluation at T0, the participants will be randomly allocated into an experimental group and a wait list control group. Specifically, cognitive training will be offered by means of technological devices (Neurotablet). At T1, all outpatients (experimental group and wait list control group) will be evaluated through MASCoD and the extensive neuropsychological evaluation for the second time.

CONDITIONS

Official Title

MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Reported subjective cognitive decline without other cognitive or neurological issues
  • Italian education
  • Adults over 55 years old
  • Understanding of research aims
  • Signed informed consent
  • Participation on a voluntary and unpaid basis
Not Eligible

You will not qualify if you...

  • Serious clinical conditions such as severe cardiac or respiratory problems, or cancer
  • Prior diagnosis of psychiatric disorders according to DSM-5
  • Prior diagnosis of cognitive decline
  • Significant vision or hearing deficits
  • Illiteracy or relapse in illiteracy
  • Refusal to participate in the research

AI-Screening

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Trial Site Locations

Total: 1 location

1

ICS Maugeri Montescano Institute

Montescano, Pavia, Italy, 27040

Actively Recruiting

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Research Team

C

Cira Fundarò, Neurologist

CONTACT

M

Marina Maffoni, Psychologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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