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NCT Number: NCT07639203

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

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.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Interdipartimentale Mente/Cervello - CIMeC

Rovereto, Trento, 38068, Italy

Location status: Recruiting

Location contact

Beatrice Feder

CONTACT

[email protected]

0039 0464808159

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

History of current or previous neurological or neuropsychiatric disorders.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 0-4 months

    Accuracy and timing

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

    Time frame: 0-4 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice Feder

CONTACT

[email protected]

0039 0464808159

Sponsors and collaborators

Lead sponsor

Università degli Studi di Trento

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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