NCT05815329

MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

Recruiting now NA Last updated 8 May 2025

What this trial tests

NA trial testing cognitive training in Cognitive Decline in 100 participants. Currently enrolling.

Timeline

2 August 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Istituti Clinici Scientifici Maugeri SpA
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	100
Start date	2 August 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Italy

Drugs / interventions tested

• cognitive training

Conditions studied

• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

55 and older, any sex, with Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The interplay between cognitive and psychological factors in subjective cognitive decline: contribution to the validation of a new screening battery.
   Maffoni M, Magnani A, Pierobon A, Mafferra A, et al · · 2025 · cited 1× · PMID 41143019 · DOI 10.3389/fpsyg.2025.1670551
2. Executive Functions and Subjective Cognitive Decline: The Moderating Role of Depressive Symptoms.
   Maffoni M, Magnani A, Pierobon A, Mafferra A, et al · · 2025 · PMID 41464165 · DOI 10.3390/diagnostics15243164