Computerized Cognitive Training in Healthy Older Adults and Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversidad Antonio de Nebrija

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

156 Participants
are divided into 4 treatment groups
Group A: Group 1. Cognitively healthy older adults assigned to active control activities.Placebo comparator 1 intervention
Group B: Group 2. Cognitively healthy older adults assigned to executive function cognitive training.Experimental treatment 1 intervention
Group C: Group 3. Older adults with MCI assigned to active control activities.Placebo comparator 1 intervention
Group D: Group 4. Older adults with MCI assigned to cognitive training of executive functions.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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).

Time frame
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.

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

Secondary outcomes

1

Trail Making Test (Part A and Part B)

Tool to assess cognitive flexibility.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

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Universidad Antonio de Nebrija

Lead sponsor

Universidad Complutense de Madrid

Collaborator