Study on the Effectiveness of the MTT24.5 Cognitive Training Program on Cognitive Skills, Brain Volume, and Activation
NCT Number: NCT06549517
Acronym: MTT245Cog
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Dysfunction
Interventions: BEHAVIORAL: Cognitive training
Sponsor: Institute for Biomedical Research, CONICET
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-03-02
Completion Date: 2023-10-30
Locations: Espacio Santa Maria, San Isidro, Buenos Aires, 1643, Argentina

Summary:
The goal of this study is to evaluate the effectiveness of a cognitive training program called Mental Training Tech 24.5 (MTT24.5). The program aims to enhance brain function and neuronal plasticity in adults who do not have any clinical cognitive impairment. This study will help determine if MTT24.5 improves cognitive abilities and affects brain volume and activation.

The Main Questions it aims to answer are:

Does MTT24.5 improve overall cognitive performance and specific areas like memory, attention, and language skills? What effects does MTT24.5 have on brain volume and activation? How well do participants follow the program, and what are their response patterns?

Study Design

* Researchers will compare the results of participation in the MTT24.5 training versus a control group with no intervention. Participants will be randomly assigned to either the MTT24.5 program or the control group.
* The study involves adults aged 30 and older from the general population who do not have clinical cognitive impairment.
* The intervention includes attending 12 weekly in-person sessions, each lasting about 2 hours, for a total of 24.5 hours.
* The study will assess cognitive performance, brain volume, and activation, as well as monitor adherence to the program and response patterns.

Participants will:

* Engage in the MTT24.5 program or the control condition as assigned.
* Complete cognitive assessments to measure performance in various domains.
* Undergo brain imaging to evaluate changes in brain volume and activation.

Primary Outcome Measures: Change in Global Cognitive Ability, The primary study outcome, cognitive ability changes, was assessed through the difference between the post intervention Addenbrooke's Cognitive Examination III (ACE) score and the pre intervention ACE score. This score ranges from 0 to 100. he ACE Score ranges from 0 to 100. A value less than 85 es considered as cognitive moderate impairment., immediately after the intervention
Secondary Outcome Measures: Change in memory, and /or attention, and/or verbal fluency, and/or language, and/or visuospatial skills abilities., Each ability outcome was assessed using the respective sub-dimensions of the ACE score and computing the difference between post intervention and pre intervention sub-score:

* Memory ability sub-score
* Attention ability sub-score
* Orientation ability sub-score
* Verbal fluency ability sub-score
* Language ability sub-score
* Visuospatial skills ability sub-score The memory ability sub-score ranges from 0 to 26, the attention abilities sub-score ranges from 0 to 8, the attention abilities sub-score ranges from 0 to 10, the verbal fluency sub-score ranges from 0 to 14, the language sub-score ranges from 0 to 16, and the visuospatial skills abilities sub-score ranges, immediately after the intervention|Rate of Adherence, Adherence or compliance with the study protocol was assessed through the number of days that participant completed ("on site days"); as participants were instructed and reminded to complete weekly sessions, the number of active days was used as the primary measure of a participant's ongoing engagement and compliance with the study protocol., immediately after the intervention|Change in Brain Volume and Activation, Changes are reported as the volumes and/or activation obtained values of different structures of the brain, both in absolute terms (cm3) and relative (% of the total), and values reference of normal populations corrected for age and sex., immediately after the intervention