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

NCT07639203 | Recruiting

• 1 other identifier: Protocollo 2024-053
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Healty; Aging and Cognitive Health

Outcome Measures

Primary Outcomes (2)

• The Tower of London Test (Bruni et al. 2020)

  Accuracy and timing

  0-4 months

• Frontal Assessment Battery (Apollonio et al., 2005)

  Minimum value: 0; Maximum value: 18; Higher scores indicate better executive functioning.

  0-4 months

Study Arms (2)

Remote Cognitive Training

EXPERIMENTAL

A group of participants randomly assigned to a remote tablet-based cognitive training intervention through individualized training sessions aimed at improving cognitive performance.

Behavioral: Remote Cognitive Training

Supervised In-Person Cognitive Training

ACTIVE COMPARATOR

A group of participants randomly assigned to an in-person supervised tablet-based cognitive training intervention consisting of individualized training sessions aimed at improving cognitive performance.

Behavioral: Supervised In-Person Cognitive Training

Interventions

Remote Cognitive Training BEHAVIORAL

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.

Remote Cognitive Training

Supervised In-Person Cognitive Training BEHAVIORAL

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.

Supervised In-Person Cognitive Training

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Cognitively healthy adults aged 65 to 75 years. Montreal Cognitive Assessment (MoCA) equivalent score ≥ 1, according to Italian normative values.

You may not qualify if:

• History of current or previous neurological or neuropsychiatric disorders.

Sponsors & Collaborators

• Università degli Studi di Trento: lead

Study Sites (1)

Centro Interdipartimentale Mente/Cervello - CIMeC

Rovereto, Trento, 38068, Italy

RECRUITING

Central Study Contacts

Beatrice Feder

CONTACT

0039 0464808159; beatrice.feder@unitn.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: September 17, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-05

Locations

IT (1)