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

2026年5月13日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

156

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Víctor Echeverry-Alzate, PhD
  • 電話番号：+34 914 521 100
  • メール：vecheverry@nebrija.es

研究連絡先のバックアップ

研究場所

  • スペイン
    • Madrid
      • Madrid、Madrid、スペイン、28040
        • 募集
        • Complutense University of Madrid
        • コンタクト：
        • 主任研究者：
          • Elena Giné Domínguez, PhD
      • Madrid、Madrid、スペイン、28015
        • 募集
        • Nebrija University
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Víctor Echeverry-Alzate, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：Group 1. Cognitively healthy older adults assigned to active control activities.
行動：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.
実験的：Group 2. Cognitively healthy older adults assigned to executive function cognitive training.
行動：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.
プラセボコンパレーター：Group 3. Older adults with MCI assigned to active control activities.
行動：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.
実験的：Group 4. Older adults with MCI assigned to cognitive training of executive functions.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Lobo's Mini Cognitive Examination (Spanish version of the MMSE)
時間枠：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)
時間枠：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)
時間枠：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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Trail Making Test (Part A and Part B)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Universidad Antonio de Nebrija

協力者

Universidad Complutense de Madrid

捜査官

  • 主任研究者：Víctor Echeverry-Alzate, PhD、Universidad Antonio de Nebrija
  • 主任研究者：Elena Giné Domínguez, PhD、Universidad Complutense de Madrid

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年6月4日

一次修了 (推定)

2028年3月1日

研究の完了 (推定)

2028年8月1日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月20日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 57_CE_20251113_MOD

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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