Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment (COGNI-AGE)
13 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
156
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Víctor Echeverry-Alzate, PhD
- Numero di telefono: +34 914 521 100
- Email: vecheverry@nebrija.es
Backup dei contatti dello studio
- Nome: Elena Giné Domínguez, PhD
- Numero di telefono: +34 913941402
- Email: elena.gine@med.ucm.es
Luoghi di studio
-
-
Madrid
-
Madrid, Madrid, Spagna, 28040
- Reclutamento
- Complutense University of Madrid
-
Contatto:
- Elena Giné Domínguez, PhD
- Numero di telefono: +34 91 3941402
- Email: elena.gine@med.ucm.es
-
Investigatore principale:
- Elena Giné Domínguez, PhD
-
Madrid, Madrid, Spagna, 28015
- Reclutamento
- Nebrija University
-
Contatto:
- Víctor Echeverry-Alzate, PhD
- Numero di telefono: +34 914 521 100
- Email: vecheverry@nebrija.es
-
Contatto:
- Ana I Beltrán Velasco, PhD
- Numero di telefono: +34 914 521 100
- Email: abeltranv@nebrija.es
-
Investigatore principale:
- Víctor Echeverry-Alzate, PhD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore 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.
|
|
Sperimentale: 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.
|
|
Comparatore 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Lobo's Mini Cognitive Examination (Spanish version of the MMSE)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Trail Making Test (Part A and Part B)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Víctor Echeverry-Alzate, PhD, Universidad Antonio de Nebrija
- Investigatore principale: Elena Giné Domínguez, PhD, Universidad Complutense de Madrid
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
4 giugno 2025
Completamento primario (Stimato)
1 marzo 2028
Completamento dello studio (Stimato)
1 agosto 2028
Date di iscrizione allo studio
Primo inviato
13 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 maggio 2026
Primo Inserito (Effettivo)
20 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 57_CE_20251113_MOD
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .