PotenziaMente: A Digital Executive Function Training Intervention for Healthy Aging in the Elderly Population

Summary

The study, entitled "PotenziaMente: Cognitive Training in Aging," is a clinical trial designed to evaluate the effectiveness of an individualized tablet-based cognitive training program targeting executive functions (e.g., planning, cognitive flexibility, and problem solving) in healthy older adults. Executive functions are higher-order cognitive processes that support adaptive functioning in daily life and influence other cognitive domains, such as memory. The primary aim of the study is to enhance cognitive performance, specifically executive functioning, in neurologically healthy adults aged 65 to 75 years. A secondary aim is to compare the effects of two different delivery modalities of the same cognitive training program: home-based self-administration via tablet versus supervised tablet-based training in the presence of a trained researcher. Participants will undergo cognitive assessments at baseline (pre-training), immediately after the intervention (post-training), and at a 3-month follow-up.

This is a randomized parallel-group interventional clinical trial without masking. Participants are randomly assigned to one of two groups: a home-based cognitive training condition, in which they perform an individualized tablet-based cognitive training program targeting executive functions independently at home via a tablet application without direct supervision, or a supervised cognitive training condition, in which they perform the same individualized tablet-based cognitive training under the supervision of a trained researcher in a controlled environment. The intervention consists of two sessions per week, 1 hour per session, for 4 consecutive weeks, delivered via tablet-based exercises. The study uses a parallel assignment model with a prospective design and a primary purpose of treatment (cognitive enhancement and prevention of cognitive decline).

The primary outcome is the change in executive functioning from baseline to post-intervention, assessed using standardized neuropsychological tests. Secondary outcomes include between-group differences (home-based vs. supervised) in executive functioning, changes in global cognitive functioning from baseline to post-intervention, and maintenance of cognitive effects at the 3-month follow-up.

Conditions

• Aging and Cognitive Health
• Healty

Interventions

BEHAVIORAL

Remote Cognitive Training

A 4-week tablet-based cognitive training intervention targeting executive functions in healthy older adults. Participants complete 2 individualized training sessions per week (1 hour each), delivered remotely via email and performed independently at home using a tablet. The intervention focuses on enhancing executive functioning, including planning, cognitive flexibility, and problem solving, with the aim of improving overall cognitive performance in daily life.

BEHAVIORAL

Supervised In-Person Cognitive Training

A 4-week tablet-based cognitive training intervention targeting executive functions in healthy older adults. Participants complete 2 individual training sessions per week (1 hour each), delivered in person under the supervision of a trained researcher in a controlled environment. The intervention focuses on enhancing executive functioning, including planning, cognitive flexibility, and problem solving, with the aim of improving overall cognitive performance in daily life.

Sponsors & Collaborators

• Università degli Studi di Trento

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-17

Primary Completion

2026-06-30

Completion

2026-09-30

Countries

• Italy

Study Locations