Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment (COGNI-AGE)

May 13, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Complutense University of Madrid
        • Contact:
        • Principal Investigator:
          • Elena Giné Domínguez, PhD
      • Madrid, Madrid, Spain, 28015
        • Recruiting
        • Nebrija University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Víctor Echeverry-Alzate, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. adults 65 years of age and older;
  2. spanish speakers;
  3. residents in Spain (urban and rural communities);
  4. elderly population that does not have dementia or other major diagnosed uncontrolled neurological disorders;
  5. 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:

  1. 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;
  2. diagnosis of dementia (e.g., Alzheimer's disease or other);
  3. uncontrolled active major psychiatric illness (major depression, schizophrenia, etc.);
  4. significant uncontrolled neurological conditions or history (e.g., Parkinson's disease, stroke, severe traumatic brain injury);
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Group 1. Cognitively healthy older adults assigned to active control activities.
Behavioral: Active Control Computerized 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.
Behavioral: Computerized 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.
Placebo Comparator: Group 3. Older adults with MCI assigned to active control activities.
Behavioral: Active Control Computerized 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.
Behavioral: Computerized 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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)
Time Frame: 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)
Time Frame: 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).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trail Making Test (Part A and Part B)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Antonio de Nebrija

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Complutense de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Víctor Echeverry-Alzate, PhD, Universidad Antonio de Nebrija
  • Principal Investigator: Elena Giné Domínguez, PhD, Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 57_CE_20251113_MOD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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