Study on the Effectiveness of the MTT24.5 Cognitive Training Program on Cognitive Skills, Brain Volume, and Activation

NCT06549517 | Completed DMC

• 1 other identifier: MTT245Cog
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Dysfunction

Keywords

ageing; cognitive dysfunction; cerebral neuroplasticiy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in memory, and /or attention, and/or verbal fluency, and/or language, and/or visuospatial skills abilities.

  immediately after the intervention

• Rate of Adherence

  immediately after the intervention

• Change in Brain Volume and Activation

  immediately after the intervention

Study Arms (2)

Intervention group-MTT24.5

ACTIVE COMPARATOR

Subjects are assigned to 12 cognitive training in-person sessions of the MTT245 program by a validated trainer. Cognitive evaluations are made initially week 1 and at the end of the intervention at week 12.

Behavioral: Cognitive training

Control group

NO INTERVENTION

Subjects are assigned to a controlled arm whereas no intervention were done. They should underwent the same cognitive evaluations than active comparator at week 1 and 12.

Interventions

Cognitive training BEHAVIORAL

MTT24.5 consists in the learning of 40 new datas or knowledges, along 24.5 hours distributted on classes or sessions, during which an average of 3.5 new pieces of knowledge are taught and reinforced through training. Participants are trained using 4 techniques assigned to each new piece of information from a total of 100 available techniques. These techniques include the use of non-dominant skills, literacy in Braille for sighted individuals, and performing 5 actions simultaneously. Each technique is designed to aid in the memorization and learning of new knowledge

Also known as: Mental Training Tech 245

Intervention group-MTT24.5

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 21 years and above.
• Ability to understand instructions for the training tasks.
• Addenbrooke Cognitive Examination score \>70.

You may not qualify if:

• Planned absences that would hinder participation in the program.
• Hearing, visual, or motor deficits that would impede participation in the program.
• History of severe degenerative neurological diseases, as these conditions may significantly impact brain plasticity and cognitive abilities.
• History of severe psychiatric disorders, as they may influence brain reorganization and complicate the interpretation of results.
• Unstable treatment or planned changes in medication that may affect brain function and alter results.
• History of current or recent excessive substance use (within the past 6 months), including alcohol or drugs, as these substances may influence brain function and neuroplasticity.

Sponsors & Collaborators

• Institute for Biomedical Research, CONICET: lead

Study Sites (1)

Espacio Santa Maria

San Isidro, Buenos Aires, 1643, Argentina

Location

Related Publications (8)

• Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.

  PMID: 32738937 BACKGROUND

• Lindenberger U. Human cognitive aging: corriger la fortune? Science. 2014 Oct 31;346(6209):572-8. doi: 10.1126/science.1254403.

  PMID: 25359964 BACKGROUND

• Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.

  PMID: 12425704 BACKGROUND

• Snowdon DA; Nun Study. Healthy aging and dementia: findings from the Nun Study. Ann Intern Med. 2003 Sep 2;139(5 Pt 2):450-4. doi: 10.7326/0003-4819-139-5_part_2-200309021-00014.

  PMID: 12965975 BACKGROUND

• Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13.

  PMID: 24417410 BACKGROUND

• Feingold A. New Approaches for Estimation of Effect Sizes and their Confidence Intervals for Treatment Effects from Randomized Controlled Trials. Quant Method Psychol. 2019;15(2):96-111. doi: 10.20982/tqmp.15.2.p096.

  PMID: 32775313 BACKGROUND

• Masic V, Secic A, Trost Bobic T, Femec L. Neuroplasticity and Braille reading. Acta Clin Croat. 2020 Mar;59(1):147-153. doi: 10.20471/acc.2020.59.01.18.

  PMID: 32724286 BACKGROUND

• Kotliar C, Olmos L, Koretzky M, Jauregui R, Delia T, Cingolani O. A new program for systematically enhancing cognitive reserve in healthy adults: A pilot randomized active-controlled clinical trial. PLoS One. 2025 Oct 1;20(10):e0331193. doi: 10.1371/journal.pone.0331193. eCollection 2025.

  PMID: 41032503 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Carol V Kotliar, PhD

  BIO

  PRINCIPAL INVESTIGATOR

• Carol V Kotliar, PhD

  Institute for Biomedical Research, CONICET

  PRINCIPAL INVESTIGATOR

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: Chief Clinical Research Laboratory

Model Details: Multisite, prospective, and open-label study involving two arms. Subjects from the general adult population were randomly assigned to either a cognitive intervention group or a no-intervention control group. The intervention consisted of in-person cognitive training over 12 weeks, with baseline and final cognitive evaluations. A sub-study will investigate neuroimaging changes in brain volume and activation as parameters of neuroplasticity stimulation

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 12, 2024
• Study Start: March 2, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 30, 2023
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: At the time of publication in a peer review journal
• Access Criteria: By written request to the PI, accompanied by a letter explaining objectives of the IPD to be shared and research group institution or antecedents of the individual if not an institution.

Locations

AR (1)