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Mild Cognitive Impairment (MCI)COGNI-AGENCT07598409

Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment

A study testing Computerized Cognitive Training in people with Mild Cognitive Impairment (MCI) and Healthy Aging, run by Universidad Antonio de Nebrija at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Computerized Cognitive Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
2 sitesSpain
Study dates
4 Jun 2025to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Víctor Echeverry-Alzate, PhD contact

+34 914 521 100

vecheverry@nebrija.es

Elena Giné Domínguez, PhD contact

+34 913941402

elena.gine@med.ucm.es

Spain2 sites, 2 recruiting
  • Nebrija University

    Madrid, Madrid, 28015

    Víctor Echeverry-Alzate, PhD, +34 914 521 100, vecheverry@nebrija.es

    Ana I Beltrán Velasco, PhD, +34 914 521 100, abeltranv@nebrija.es

    Recruiting
  • Complutense University of Madrid

    Madrid, Madrid, 28040

    Elena Giné Domínguez, PhD, +34 91 3941402, elena.gine@med.ucm.es

    Elena Giné Domínguez, PhD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Computerized Cognitive Training, Active Control Computerized Activities
Keywords
Computarized Cognitive Training, Healthy Cognition, Mild Cognitive Impairment, Older adults, Cognition, Executive functions, Transfer, Emotional symptoms, Behavioral disorders, Quality of life, Memory
Medical subject headings
Cognitive Dysfunction, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized Cognitive TrainingBehavioural

    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.

  • Active Control Computerized ActivitiesBehavioural

    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.

Study groups in NCT07598409
Study groupRoleWhat they receive
Group 1. Cognitively healthy older adults assigned to active control activities.Placebo comparatorNot described
Receives: Behavioral: Active Control Computerized Activities
Group 2. Cognitively healthy older adults assigned to executive function cognitive training.ExperimentalNot described
Receives: Behavioral: Computerized Cognitive Training
Group 3. Older adults with MCI assigned to active control activities.Placebo comparatorNot described
Receives: Behavioral: Active Control Computerized Activities
Group 4. Older adults with MCI assigned to cognitive training of executive functions.ExperimentalNot described
Receives: Behavioral: Computerized Cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lobo's Mini Cognitive Examination (Spanish version of the MMSE)

    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.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  2. CogniFit Cognitive Assessment Battery for Reasoning (CAB-RS)

    Evaluation of several executive aspects (e.g., cognitive flexibility, inhibition, working memory, monitoring, planning, and processing speed).

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  3. CogniFit Cognitive Assessment Battery for Memory (CAB-ME)

    Assessment of several measurement skills: contextual memory, verbal memory, visual memory, immediate short-term memory, working memory, non-verbal memory, and recognition.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

Secondary outcomes (7)
  1. Trail Making Test (Part A and Part B)

    Tool to assess cognitive flexibility.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  2. Digit Span Test (Modalities: Digital Span Forward and Digital Span Backward)

    Assessment of verbal working memory, sustained attention, and information processing. The specified modalities will be used.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  3. Yesavage Geriatric Depression Scale (Spanish adaptation)

    Utility scale for detecting depressive symptoms.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  4. Geriatric Anxiety Inventory (Spanish adaptation)

    Utility inventory to explore common anxiety symptoms.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  5. Neuropsychiatric Inventory Questionnaire (Spanish adaptation)

    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.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  6. FUMAT Quality of Life Scale

    To measure individual's perception in different dimensions of quality of life.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

  7. Lawton & Brody Instrumental Activities of Daily Living Scale

    Scale designed to assess the level of functional competence, through the evaluation of the autonomy in instrumental activities necessary for independent living.

    Measured: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2026
  2. Study start4 Jun 2025
  3. Primary completionMar 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial with a longitudinal 2 × 2 factorial design, parallel groups, and repeated measures at baseline, post-intervention, and follow-up.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07598409
Sponsor's protocol ID
57_CE_20251113_MOD
Acronym
COGNI-AGE
Status last verified
May 2026
First submitted
13 May 2026
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Cognitive Training in people with Mild Cognitive Impairment (MCI) and Healthy Aging, run by Universidad Antonio de Nebrija at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Víctor Echeverry-Alzate, PhD (+34 914 521 100, vecheverry@nebrija.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lobo's Mini Cognitive Examination (Spanish version of the MMSE) (time frame: Baseline value (pretest), 8/12 weeks after the intervention (posttest) and 3 months after the intervention ended (follow-up).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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