Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment (COGNI-AGE)
13 de maio de 2026 atualizado por: Víctor Echeverry Alzate, Universidad Antonio de Nebrija
Computerized Executive Function Training in Healthy Older Adults and Individuals With Mild Cognitive Impairment: Transfer Effects on Memory and Emotional Outcomes. A Randomized Controlled Trial
The overall objective of this study is to assess the effect of an adaptive computerized cognitive training program for executive functions (CogniFit platform) on improving these functions in older adults, both healthy and with mild cognitive impairment (MCI), as well as to examine the potential transfer effects of this training on memory.
Additionally, determine the impact of the intervention on the emotional symptoms, behavioral disorders, or quality of life of the participants.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
Population aging leads to an increase in the prevalence of cognitive decline, which negatively affects the autonomy and quality of life of older adults.
In turn, the mild cognitive impairment (MCI) is an intermediate state between normal aging and dementia. The impact of adaptive computerized cognitive training (CCT) specifically focused on executive functions in older adults with healthy cognition and MCI has not yet been sufficiently explored.
Additionally, the following stand out in both conditions: small sample sizes, limited duration, a lack of evidence regarding transfer effects to memory, insufficient knowledge of the actual impact on the emotional health, behavioral disorders, or quality of life, among other factors.
Among the main questions it aims to answer are:
- What are the initial differences in emotional symptoms (depression, anxiety), behavioral disorders, and quality of life between healthy older adults and adults with MCI, before the intervention?
- Are there any improvements in emotional and functional well-being following the program intervention?
- What are the effects of executive function training (adaptive CCT) on improving performance in executive functions?
- Is there a transfer from trained executive functions to untrained memory domains directly?
Recruitment is carried out in day care centers and nursing homes that have shown collaboration with the university and have agreed to conduct the study. This recruitment takes place in Spain, in different autonomous communities.
Participants aged 65 years and older will be randomly assigned to one of four experimental conditions, defined by the combination of cognitive status (healthy aging vs. MCI) and type of intervention (training vs. active control). Accordingly, four experimental groups will be established.
Participants in this study will complete three in-person assessments: baseline (prior to cognitive training), post-intervention, and a three-month follow-up assessment. Each assessment session will last approximately two hours per participant. Assessments will be conducted by a multidisciplinary research team composed of psychologists, neuropsychologists, and neuroscientists with expertise in cognitive aging and cognitive interventions.
The intervention will last between 8 and 12 weeks, with participants completing approximately two to three training sessions per week. Training sessions will be conducted in small groups (approximately 3-5 participants) under the supervision of a psychologist from the research team, in designated rooms within each residence equipped with tables and tablets provided by the research team.
The executive function cognitive training program will be implemented using the CogniFit platform (CogniFit Inc ©) in research mode.
Tipo de estudo
Intervencional
Inscrição (Estimado)
156
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Víctor Echeverry-Alzate, PhD
- Número de telefone: +34 914 521 100
- E-mail: vecheverry@nebrija.es
Estude backup de contato
- Nome: Elena Giné Domínguez, PhD
- Número de telefone: +34 913941402
- E-mail: elena.gine@med.ucm.es
Locais de estudo
-
-
Madrid
-
Madrid, Madrid, Espanha, 28040
- Recrutamento
- Complutense University of Madrid
-
Contato:
- Elena Giné Domínguez, PhD
- Número de telefone: +34 91 3941402
- E-mail: elena.gine@med.ucm.es
-
Investigador principal:
- Elena Giné Domínguez, PhD
-
Madrid, Madrid, Espanha, 28015
- Recrutamento
- Nebrija University
-
Contato:
- Víctor Echeverry-Alzate, PhD
- Número de telefone: +34 914 521 100
- E-mail: vecheverry@nebrija.es
-
Contato:
- Ana I Beltrán Velasco, PhD
- Número de telefone: +34 914 521 100
- E-mail: abeltranv@nebrija.es
-
Investigador principal:
- Víctor Echeverry-Alzate, PhD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- adults 65 years of age and older;
- spanish speakers;
- residents in Spain (urban and rural communities);
- elderly population that does not have dementia or other major diagnosed uncontrolled neurological disorders;
- the initial cognitive state will be determined by a global screening test, the Lobo's Mini Cognitive Examination, that is, the spanish version of the Mini-Mental State Examination (MMSE); and 6) all participants must provide their signed written informed consent indicating that the individual has been informed of the relevant aspects of the study (and may withdraw from the study at any time if they so request).
Exclusion Criteria:
- Older adults who obtain scores indicative of severe impairment (to be determined for low MEC scores that are suggestive of incipient dementia) or whose medical condition prevents them from participating safely;
- diagnosis of dementia (e.g., Alzheimer's disease or other);
- uncontrolled active major psychiatric illness (major depression, schizophrenia, etc.);
- significant uncontrolled neurological conditions or history (e.g., Parkinson's disease, stroke, severe traumatic brain injury);
- uncontrolled decompensated chronic medical conditions (e.g., diabetes, cardiovascular disease) that may affect cognition or attendance at sessions; and 6) severe uncorrected sensory disabilities (e.g., blindness or severe hearing loss) that interfere with the performance of tasks on tablets.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Group 1. Cognitively healthy older adults assigned to active control activities.
|
Participants in the active control groups (Group 1: healthy control; Group 3: MCI control) will also use the CogniFit platform.
However, in this condition, participants will engage in simple recreational computerized activities designed to control for screen exposure, participant engagement, and expectancy effects (e.g., digital coloring tasks, visual puzzles, and contour-tracing activities), without specifically targeting higher-order cognitive functions.
Participants will complete sessions lasting approximately 15-30 minutes, at least twice per week, over a period of 8-12 weeks.
|
|
Experimental: Group 2. Cognitively healthy older adults assigned to executive function cognitive training.
|
Participants in the experimental groups (Group 2: trained healthy individuals; Group 4: trained individuals with mild cognitive impairment) will use an online cognitive training platform (CogniFit®) consisting of multiple interactive games designed to train reasoning and executive functions.
Training activities will target key executive processes related to reasoning, including processing speed, planning, working memory updating, focused attention, cognitive flexibility, and response inhibition.
Each session will consist of several short games or exercises presented on a tablet screen, which participants will complete by following simple instructions and receiving immediate feedback on their performance.
Exercise difficulty will automatically adapt to participants' performance, as the activities are designed to impose a relatively high cognitive demand.
Participants will complete sessions lasting approximately 15-30 minutes, at least twice per week, over a period of 8-12 weeks.
|
|
Comparador de Placebo: Group 3. Older adults with MCI assigned to active control activities.
|
Participants in the active control groups (Group 1: healthy control; Group 3: MCI control) will also use the CogniFit platform.
However, in this condition, participants will engage in simple recreational computerized activities designed to control for screen exposure, participant engagement, and expectancy effects (e.g., digital coloring tasks, visual puzzles, and contour-tracing activities), without specifically targeting higher-order cognitive functions.
Participants will complete sessions lasting approximately 15-30 minutes, at least twice per week, over a period of 8-12 weeks.
|
|
Experimental: Group 4. Older adults with MCI assigned to cognitive training of executive functions.
|
Participants in the experimental groups (Group 2: trained healthy individuals; Group 4: trained individuals with mild cognitive impairment) will use an online cognitive training platform (CogniFit®) consisting of multiple interactive games designed to train reasoning and executive functions.
Training activities will target key executive processes related to reasoning, including processing speed, planning, working memory updating, focused attention, cognitive flexibility, and response inhibition.
Each session will consist of several short games or exercises presented on a tablet screen, which participants will complete by following simple instructions and receiving immediate feedback on their performance.
Exercise difficulty will automatically adapt to participants' performance, as the activities are designed to impose a relatively high cognitive demand.
Participants will complete sessions lasting approximately 15-30 minutes, at least twice per week, over a period of 8-12 weeks.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Lobo's Mini Cognitive Examination (Spanish version of the MMSE)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
The study uses the Lobo's Mini Cognitive Examination (Spanish version of the MMSE) to assess cognitive function in the pretest to characterize participants.
It will be repeated in the posttest after the computerized cognitive training intervention and follow-up.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
CogniFit Cognitive Assessment Battery for Reasoning (CAB-RS)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Evaluation of several executive aspects (e.g., cognitive flexibility, inhibition, working memory, monitoring, planning, and processing speed).
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
CogniFit Cognitive Assessment Battery for Memory (CAB-ME)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Assessment of several measurement skills: contextual memory, verbal memory, visual memory, immediate short-term memory, working memory, non-verbal memory, and recognition.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Trail Making Test (Part A and Part B)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Tool to assess cognitive flexibility.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
Digit Span Test (Modalities: Digital Span Forward and Digital Span Backward)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Assessment of verbal working memory, sustained attention, and information processing.
The specified modalities will be used.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
Yesavage Geriatric Depression Scale (Spanish adaptation)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Utility scale for detecting depressive symptoms.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
Geriatric Anxiety Inventory (Spanish adaptation)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Utility inventory to explore common anxiety symptoms.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
Neuropsychiatric Inventory Questionnaire (Spanish adaptation)
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
A brief questionnaire directed to an informant (e.g., caregiver or family member) that rates the presence and severity of various behavioral symptoms in the older adult.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
FUMAT Quality of Life Scale
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
To measure individual's perception in different dimensions of quality of life.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
|
Lawton & Brody Instrumental Activities of Daily Living Scale
Prazo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Scale designed to assess the level of functional competence, through the evaluation of the autonomy in instrumental activities necessary for independent living.
|
Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Víctor Echeverry-Alzate, PhD, Universidad Antonio de Nebrija
- Investigador principal: Elena Giné Domínguez, PhD, Universidad Complutense de Madrid
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de junho de 2025
Conclusão Primária (Estimado)
1 de março de 2028
Conclusão do estudo (Estimado)
1 de agosto de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
13 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de maio de 2026
Primeira postagem (Real)
20 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 57_CE_20251113_MOD
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Individual participant data underlying the results reported in publications derived from this study will be available in de-identified form upon reasonable request to the principal investigator, following publication and subject to institutional ethics approval and data-sharing agreements.
Prazo de Compartilhamento de IPD
De-identified individual participant data and supporting materials will be available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.
Critérios de acesso de compartilhamento IPD
De-identified individual participant data, study protocol, and informed consent form will be made available to qualified researchers upon reasonable request to the principal investigator.
Access will be granted for scientific research purposes following publication of the primary study results and subject to institutional ethics approval and applicable data-sharing agreements.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .