Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment (COGNI-AGE)
13 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
156
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Víctor Echeverry-Alzate, PhD
- Número de teléfono: +34 914 521 100
- Correo electrónico: vecheverry@nebrija.es
Copia de seguridad de contactos de estudio
- Nombre: Elena Giné Domínguez, PhD
- Número de teléfono: +34 913941402
- Correo electrónico: elena.gine@med.ucm.es
Ubicaciones de estudio
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Madrid
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Madrid, Madrid, España, 28040
- Reclutamiento
- Complutense University of Madrid
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Contacto:
- Elena Giné Domínguez, PhD
- Número de teléfono: +34 91 3941402
- Correo electrónico: elena.gine@med.ucm.es
-
Investigador principal:
- Elena Giné Domínguez, PhD
-
Madrid, Madrid, España, 28015
- Reclutamiento
- Nebrija University
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Contacto:
- Víctor Echeverry-Alzate, PhD
- Número de teléfono: +34 914 521 100
- Correo electrónico: vecheverry@nebrija.es
-
Contacto:
- Ana I Beltrán Velasco, PhD
- Número de teléfono: +34 914 521 100
- Correo electrónico: abeltranv@nebrija.es
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Investigador principal:
- Víctor Echeverry-Alzate, PhD
-
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Group 1. Cognitively healthy older adults assigned to active control activities.
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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.
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Experimental: Group 2. Cognitively healthy older adults assigned to executive function cognitive training.
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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.
|
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Comparador de placebos: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lobo's Mini Cognitive Examination (Spanish version of the MMSE)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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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.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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CogniFit Cognitive Assessment Battery for Reasoning (CAB-RS)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Evaluation of several executive aspects (e.g., cognitive flexibility, inhibition, working memory, monitoring, planning, and processing speed).
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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CogniFit Cognitive Assessment Battery for Memory (CAB-ME)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Assessment of several measurement skills: contextual memory, verbal memory, visual memory, immediate short-term memory, working memory, non-verbal memory, and recognition.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Trail Making Test (Part A and Part B)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Tool to assess cognitive flexibility.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Digit Span Test (Modalities: Digital Span Forward and Digital Span Backward)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Assessment of verbal working memory, sustained attention, and information processing.
The specified modalities will be used.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Yesavage Geriatric Depression Scale (Spanish adaptation)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Utility scale for detecting depressive symptoms.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Geriatric Anxiety Inventory (Spanish adaptation)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Utility inventory to explore common anxiety symptoms.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Neuropsychiatric Inventory Questionnaire (Spanish adaptation)
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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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.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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FUMAT Quality of Life Scale
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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To measure individual's perception in different dimensions of quality of life.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Lawton & Brody Instrumental Activities of Daily Living Scale
Periodo de tiempo: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Scale designed to assess the level of functional competence, through the evaluation of the autonomy in instrumental activities necessary for independent living.
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Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Víctor Echeverry-Alzate, PhD, Universidad Antonio de Nebrija
- Investigador principal: Elena Giné Domínguez, PhD, Universidad Complutense de Madrid
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de junio de 2025
Finalización primaria (Estimado)
1 de marzo de 2028
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 57_CE_20251113_MOD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Active Control Computerized Activities
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Universidad Complutense de MadridDesconocidoDesempeño atléticoEspaña