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Recruiting Not applicable

MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

NCT05815329 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2022-08-02
Last updated
2025-05-08

Condition(s) studied

Cognitive Decline

Investigational drug(s) / intervention(s)

cognitive training

cognitive training: 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 to half of the outpatients included in this research by means of technological devices (Neurotablet). A neuropsychologist will supervise the cognitive training offline (about 30 minutes per 5 days, 8 weeks) and through a face-to-face 1 hour-session each week per each outpatient.

Study summary

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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * reported subjective cognitive decline without any other cognitive or neurological issue, * Italian education, * adult (\> 55 years old), * understanding of research aims, * signed informed consent, * participation on a voluntary and non-payied bases. Exclusion Criteria: * serious clinical conditions (e.g. severe cardiac and respiratory problems, neoplasia) * prior diagnosis of psychiatric disorders according to DSM-5, * prior diagnosis of cognitive decline, * relevant visuo-perceptive or hearing deficits, * illiteracy or relapse in illiteracy, * refusal to partake in the research.

Primary outcome measure(s)

  • instrument validation — baseline
    To assess the construct and clinical validity, and tune the clinical cutoffs of the new instrument MASCoD

Trial sites (1)

FacilityCityRegionStatus
ICS Maugeri Montescano Institute Montescano Pavia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05815329 on ClinicalTrials.gov ↗ ← All trials in Italy