Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment

NCT07598409 | Recruiting DMC

• 1 other identifier: 57_CE_20251113_MOD
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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 this training on memory. Additionally, determine the impact of the intervention on the emotional symptoms, behavioral disorders, or quality of life of the participants.

Conditions

Mild Cognitive Impairment (MCI); Healthy Aging

Keywords

Computarized Cognitive Training; Healthy Cognition; Mild Cognitive Impairment; Older adults; Cognition; Executive functions; Transfer; Emotional symptoms; Behavioral disorders; Quality of life; Memory

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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)

  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 Outcomes (7)

• Trail Making Test (Part A and Part B)

  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)

  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)

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

• Geriatric Anxiety Inventory (Spanish adaptation)

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

• Neuropsychiatric Inventory Questionnaire (Spanish adaptation)

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

Study Arms (4)

Group 1. Cognitively healthy older adults assigned to active control activities.

PLACEBO COMPARATOR

Behavioral: Active Control Computerized Activities

Group 2. Cognitively healthy older adults assigned to executive function cognitive training.

EXPERIMENTAL

Behavioral: Computerized Cognitive Training

Group 3. Older adults with MCI assigned to active control activities.

PLACEBO COMPARATOR

Behavioral: Active Control Computerized Activities

Group 4. Older adults with MCI assigned to cognitive training of executive functions.

EXPERIMENTAL

Behavioral: Computerized Cognitive Training

Interventions

Computerized Cognitive Training BEHAVIORAL

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.

Group 2. Cognitively healthy older adults assigned to executive function cognitive training.; Group 4. Older adults with MCI assigned to cognitive training of executive functions.

Active Control Computerized Activities BEHAVIORAL

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.

Group 1. Cognitively healthy older adults assigned to active control activities.; Group 3. Older adults with MCI assigned to active control activities.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Antonio de Nebrija: lead
• Universidad Complutense de Madrid: collaborator

Study Sites (2)

Nebrija University

Madrid, Madrid, 28015, Spain

RECRUITING

Complutense University of Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Mental Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders

Study Officials

• Víctor Echeverry-Alzate, PhD

  Universidad Antonio de Nebrija

  PRINCIPAL INVESTIGATOR

• Elena Giné Domínguez, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Víctor Echeverry-Alzate, PhD

CONTACT

+34 914 521 100; vecheverry@nebrija.es

Elena Giné Domínguez, PhD

CONTACT

+34 913941402; elena.gine@med.ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will follow a single-blind design in which participants and outcome assessors will remain blinded to group allocation. Participants will be informed that they are taking part in a cognitive stimulation program but will not be informed about the existence of different intervention conditions. In addition, research team members responsible for administering cognitive and emotional assessments (excluding personnel supervising the intervention sessions) will remain blinded to group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator NBC group

Model Details: Randomized controlled trial with a longitudinal 2 × 2 factorial design, parallel groups, and repeated measures at baseline, post-intervention, and follow-up.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: June 4, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

ES (2)