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Background Computerised cognitive training (CCT) can improve the cognitive abilities of people with mild cognitive impairment (MCI), especially when the CCT contains a learning system, which is a type of machine learning (ML) that automatically selects exercises at a difficulty that corresponds to the person’s peak performance and thus enables individualised training. Methods We developed one individualised CCT (iCCT) with ML and one basic CCT (bCCT) for an active control group (CG). The study aimed to determine whether iCCT in the intervention group (IG) resulted in significantly greater enhancements in overall cognitive functioning for individuals with MCI (age 60+) compared with bCCT in the CG across a 6-month period. This double-blind randomised controlled study was conducted entirely virtually. The 89 participants were community-dwelling people with a psychometric diagnosis of MCI living in Germany. The iCCT stimulates various cognitive functions, especially working memory, visuo-constructional reasoning, and decision-making. The bCCT includes fewer and simpler tasks. Both CCTs were used at home. At baseline and after 6 months, we assessed cognitive functioning with the Montreal Cognitive Assessment (MoCA). A mixed-model ANCOVA was conducted as the main analysis. Results Both CCTs led to significant increases in average global cognition. The estimated marginal means of the MoCA score increased significantly in the CG by an average of 0.9 points (95% CI [0.2, 1.7]) from 22.3 ( SE  = 0.25) to 23.2 ( SE  = 0.41) points ( p  = 0.018); in the IG, the MoCA score increased by an average of 2.2 points (95% CI [1.4, 2.9]) from 21.9 ( SE  = 0.26) to 24.1 ( SE  = 0.42) points ( p  < 0.001). In a confound-adjusted multiple regression model, the interaction between time and group was statistically significant ( F  = 4.92; p  = 0.029). The effect size was small to medium (partial η 2  = 0.057). On average, the participants used the CCTs three times per week with an average duration of 34.9 min per application. The iCCT was evaluated as more attractive and more stimulating than the bCCT. Conclusions By using a multi-tasking CCT three times a week for 30 min, people with MCI living at home can significantly improve their cognitive abilities within 6 months. The use of ML significantly increases the effectiveness of cognitive training and improves user satisfaction. Trial registration ISRCTN14437015; registered February 27, 2020.

IntroductionThe prevalence of dementia is increasing, both worldwide and in China. This disease is associated with numerous restrictions for those affected but also for caregivers and society. Due to the limited effectiveness of pharmacological interventions, more research on non-pharmacological interventions is needed. For the non-pharmacological multimodal MAKS (M: motor training, A: activities of daily living training, K: cognitive training, S: social-communicative setting) intervention, positive effects on cognition, activities of daily living, and the occurrence of behavioural and psychological symptoms of dementia were identified in two randomised controlled trials in different settings in Germany. Thus, the German MAKS intervention was culturally adapted for China and will now be tested for its efficacy in Chinese nursing homes in a randomised controlled trial.Methods and analysisParticipants will be residents of Chinese nursing homes in Shenyang, Nanjing and Dalian, fulfilling the ICD-10 criteria for Alzheimer’s dementia, the psychometric criteria for mild to moderate dementia (MMSE 10–23) and none of the exclusion criteria. With n=200, effects with an effect size of Cohen’s d=0.45 and a power of 1-β = 0.80 can be detected. Screening and data collection at baseline, t6 and t12 will be conducted via face-to-face contact by proxy raters in the nursing homes (i.e., trained nursing staff not involved in the intervention) and master students as external testers for the performance tests on cognition and activities of daily living. Participants will be randomly allocated to the intervention or control group. SinoMAKS (i.e., the Chinese version of the MAKS intervention) will be conducted at least three times a week for six months by trained MAKS therapists. The control group will receive care as usual for 12 months after baseline. Thus, the treatment phase is six months with follow-ups after six and 12 months after baseline. In the open phase, from t6 to t12, the nursing homes are free to offer SinoMAKS to the intervention group residents. In line with international guidelines, the primary population for analysis is the intention-to-treat sample. Global cognition (measured with the Addenbrooke’s Cognitive Examination-III) is the primary outcome. The hypotheses will be analysed using multiple linear regression with the outcome variables as dependent variables.Ethics and disseminationAll procedures were approved by the Ethics Committee of the Medical Faculty of the Friedrich-Alexander-Universität Erlangen-Nürnberg (Ref. 24–162-B) and the Ethics Committee of the China Medical University (Ref. [2024]181). Written informed consent will be obtained from all participants or—if applicable—their legal representatives. Results will be published in peer-reviewed scientific journals and conference presentations.Trial registration numberISRCTN10262531.

Background Computerized cognitive training (CCT) is effective for people with mild cognitive impairment (MCI). But CCT must be “user friendly” and easy to handle for this target group. Objective The aim of this study was to evaluate in a secondary data analysis the user experience with two CCT programs developed for people with MCI. Methods In the framework of the randomized controlled study BrainFit-Nutrition ( N  = 270), two CCTs were examined: an individualized CCT (iCCT) with a machine learning system and more exercises versus a basic CCT (bCCT) with less exercises and without machine learning: both containing a set of cognitive training tasks. The User Experience Questionnaire (UEQ) was used to evaluate user satisfaction with the two CCTs at t6-follow-up ( n UX =217; n UX−iCCT =109; n UX−bCCT =108). In addition to the benchmark, we examined, first, the differences between the CCTs; second, the correlation between self-reported training intensity and user satisfaction; and third, age and gender differences in the use of the CCTs. Results For both CCT programs, the benchmark was above average or good for all scales. There were no significant differences between the CCT programs in 5 of the 6 UEQ scales. Only the Perspicuity scale showed significantly higher values for the bCCT than for the iCCT. Training intensity was positively correlated with the UEQ aspects Attractiveness, and hedonic quality (i.e. the scales Stimulation and Novelty) for each CCT program. Conclusion Both CCT programs are user-friendly tools for individuals with MCI aged 60 years and older. Participants who used one of the CCT programs more frequently were more satisfied with the hedonic quality of the CCT program, whereby the training intensity of the iCCT was descriptively higher than in the bCCT. The results are very important, due to the rising number of persons with MCI and the need to offer various non-pharmacological intervention, that can be offered at a low threshold. Trial registration ISRCTN10560738; registered November 23, 2021.

Objective The aim of this study was to compare the Montreal Cognitive Assessment (MoCA) performances of people who report no, subclinical, and clinical symptoms of depression. Methods Data was collected for the randomized controlled trial BrainFit-Nutrition. A secondary data analysis of 1,111 participants (age ≥ 60 years; M  = 68.4 years; 55.1% female) was performed. Depressive symptoms were assessed with the Patient Health Questionnaire-9 (PHQ-9), cognitive performance was assessed via the MoCA. Performance differences were tested with Kruskal-Wallis tests. Two sensitivity analyses were conducted, one with data from people with MCI and one with the original item structure of the MoCA. Results No differences were found in the MoCA total score or in visuospatial, executive functioning, attention, memory, or orientation subscores between individuals with no, subclinical, or clinical symptoms of depression. A sensitivity analysis also showed no differences. Conclusion Cognitive screening with the MoCA seems to be robust against depression and could therefore be used to screen for MCI regardless of depression level. Trial registration The study was prospectively registered at the International Standard Randomized Controlled Trial Number Registry on 23/11/2021 (ISRCTN 10560738).

IntroductionPeople with mild cognitive impairment (MCI) are at increased risk of decreasing cognitive functioning. Computerised cognitive training (CCT) and nutrition have been shown to improve the cognitive capacities of people with MCI. For each variable, we developed two kinds of interventions specialised for people with MCI (CCT: ‘individualised’ CCT; nutrition: a whole-food, plant-based diet). Additionally, there are two kinds of active control measures (CCT: ‘basic’ CCT; nutrition: a healthy diet following the current guidelines of the German Nutrition Society). The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants.Methods and analysisParticipants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. With N=200, effects with an effect size of f≥0.24 (comparable to Cohen’s d≥0.48) can be detected. Screening, baseline, t6 and t12 testing will be conducted via a videoconferencing assessment, telephone, and online survey. Participants will be randomly allocated to one of four groups and will receive a combination of CCT and online nutritional counselling. The CCT can be carried out independently at home on a computer, laptop, or tablet. Nutrition counselling includes 12 online group sessions every fortnight for 1.5 hours. The treatment phase is 6 months with follow-ups after six and 12 months after baseline.Ethics and disseminationAll procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). Written informed consent will be obtained from all participants. Results will be published in peer-reviewed scientific journals, conference presentations.Trial registration numberISRCTN10560738.

Background Patient engagement (PE) in clinical trials has gained importance yet remains uncommon, particularly in patients with mild cognitive impairment (MCI), a critical precursor to Alzheimer’s disease (AD). Cannabidiol (CBD) shows potential in slowing MCI progression due to its neuroprotective and anti-inflammatory properties. In CBD research, PE is underutilized too. To design a study on CBD for MCI, we administered an online survey to individuals with MCI to better understand their preferences for trial setup and outcomes. Methods We asked 209 individuals with MCI to complete an online survey assessing (i) willingness to participate in a trial using CBD; (ii) importance of improvements in various domains; (iii) acceptance of adverse events (AEs); (iv) reasons for AE-related dropout; (v) willingness to undergo blood sampling and lumbar puncture to assess AD pathology; and (vi) willingness to participate in a trial with a 50% chance of receiving a placebo. Data were analyzed with descriptive statistics. Results N  = 118 agreed to participate and N  = 88 completed the survey. Participants prioritized improvement in cognitive abilities (87.5%), followed by quality of life (63.6%), daily activities (55.7%), sleep (55.7%), pain (52.3%), mood (52.3%), behavior (48.9%), and anxiety (43.2%). Headache (55.7%) was the least accepted AE followed by nausea (46.6%), fatigue (35.2%), and diarrhea (35.2%). Persistent diarrhea (90.9%) and severe fatigue (84.1%) were the main reasons for potential dropout. While most would undergo blood sampling (67.0%), only a minority (21.6%) would accept lumbar puncture. One-third were ready to participate (34.1%), while 54.5% were interested pending details. Among those in favor of participation, 71.6% would participate even with a 50% chance of placebo. Conclusions Our study identified cognitive improvement as highly relevant for patients, indicating cognitive assessment tools as primary endpoints in MCI research. Given concerns about AEs, dose titration should be carefully considered to enhance acceptance and prevent AEs. Blood sampling seems well-accepted for AD biomarker assessment. Despite potential AEs, participation in a trial using CBD for MCI is seen as attractive, even under placebo-controlled conditions. This cross-sectional study emphasizes the importance of patient engagement in designing high-quality trials for using CBD to treat MCI.

Computerised cognitive training (CCT) can improve the cognitive abilities of people with mild cognitive impairment (MCI), especially when the CCT contains a learning system, which is a type of machine learning (ML) that automatically selects exercises at a difficulty that corresponds to the person's peak performance and thus enables individualised training. We developed one individualised CCT (iCCT) with ML and one basic CCT (bCCT) for an active control group (CG). The study aimed to determine whether iCCT in the intervention group (IG) resulted in significantly greater enhancements in overall cognitive functioning for individuals with MCI (age 60+) compared with bCCT in the CG across a 6-month period. This double-blind randomised controlled study was conducted entirely virtually. The 89 participants were community-dwelling people with a psychometric diagnosis of MCI living in Germany. The iCCT stimulates various cognitive functions, especially working memory, visuo-constructional reasoning, and decision-making. The bCCT includes fewer and simpler tasks. Both CCTs were used at home. At baseline and after 6 months, we assessed cognitive functioning with the Montreal Cognitive Assessment (MoCA). A mixed-model ANCOVA was conducted as the main analysis. Both CCTs led to significant increases in average global cognition. The estimated marginal means of the MoCA score increased significantly in the CG by an average of 0.9 points (95% CI [0.2, 1.7]) from 22.3 (SE = 0.25) to 23.2 (SE = 0.41) points (p = 0.018); in the IG, the MoCA score increased by an average of 2.2 points (95% CI [1.4, 2.9]) from 21.9 (SE = 0.26) to 24.1 (SE = 0.42) points (p < 0.001). In a confound-adjusted multiple regression model, the interaction between time and group was statistically significant (F = 4.92; p = 0.029). The effect size was small to medium (partial η.sup.2 = 0.057). On average, the participants used the CCTs three times per week with an average duration of 34.9 min per application. The iCCT was evaluated as more attractive and more stimulating than the bCCT. By using a multi-tasking CCT three times a week for 30 min, people with MCI living at home can significantly improve their cognitive abilities within 6 months. The use of ML significantly increases the effectiveness of cognitive training and improves user satisfaction.

Limitations in daily living have not yet been described adequately for mild cognitive impairment (MCI). In this study, we investigated first, time spent on protective activities (social, mental, and physical) and second, limitations in practical skills of daily living, both for people with MCI. We used baseline data from 270 individuals who participated in the randomized controlled trial BrainFit-Nutrition. The Montreal Cognitive Assessment (MoCA) was used to identify people with MCI. Participants were asked how much time they spent engaged in social, mental, and physical activities each week. Furthermore, the Bayer-ADL scale was used to quantify deficits in activities of daily living (ADLs). Regarding protection, the number of hours spent engaged in the three activity areas was significantly correlated with the cognitive performance in people with MCI. Social activities were positively associated with current cognitive performance. Concerning the limitations in practical skills of daily living, older and more cognitively impaired individuals were affected. Memory and orientation appear to be among the first practical skills of daily living that become impaired in people with MCI. Treatment recommendations for people with MCI include an increase in social, mental, and physical activities as well as the promotion of a healthy lifestyle.

Hintergrund und Ziele:Der Anteil der pflegebedürftigen Personen an der Gesamtbevölkerung steigt in Deutschland kontinuierlich an. Aktuell gelten laut des Statistischen Bundesamtes etwa fünf Millionen Menschen als pflegebedürftig, wovon die meisten zu Hause, überwiegend von ihren Angehörigen, gepflegt werden. Für diese häusliche Pflege werden ambulante Unterstützungsangebote benötigt, um die steigende Anzahl von pflegebedürftigen Menschen im häuslichen Umfeld versorgen zu können und ihre Angehörige zu entlasten. Da es sich bei den Angehörigen vorwiegend um jüngere und noch erwerbstätige, weibliche Personen handelt, sind ambulante Entlastungsangebote für die Aufrechterhaltung der häuslichen Pflege notwendig. Der ambulante Pflegedienst ist dabei das mit Abstand am häufigsten genutzte Angebot. Um dieses Angebot möglichst zu optimieren, ist es wichtig zu erfahren, von welchen Personen es genutzt wird und wer in Zukunft eine Nutzung des Angebots beabsichtigt. Somit ist das Ziel der vorliegenden Dissertation zum einen die Untersuchung der aktuellen und der in Zukunft beabsichtigten Nutzung der ambulanten Entlastungsangebote. Zum anderen sollen die Einflussfaktoren auf die Nutzung des ambulanten Pflegedienstes analysiert werden.Methoden:Die vorliegende Dissertation bezieht Daten aus der Querschnittstudie „Benefits of Being a Caregiver“ („Zugewinne durch die Pflege“). Im Rahmen der „Benefits“-Studie wurden pflegende Angehörige von pflegebedürftigen Menschen zu der Pflegesituation, der Pflegebelastung sowie zur Nutzung von verschiedenen Unterstützungsangeboten befragt. In der vorliegenden Arbeit wurde zum einen die Nutzung von acht ambulanten Entlastungsangeboten untersucht: ambulanter Pflegedienst, Tagespflege, 24-StundenBetreuung, Betreuungsgruppe, Betreuungsdienst, Haushaltshilfe, Essen auf Rädern, Fahrdienst. Zum anderen wurden Prädiktoren für die gegenwärtige sowie die in Zukunft beabsichtigte Nutzung des ambulanten Pflegedienstes ermittelt. Die Berechnungen erfolgten mittels bivariater Vergleiche und binär-logistischer Regressionen.Ergebnisse und Beobachtungen:Es zeigte sich, dass pflegende Angehörige trotz einer hohen Belastung und des Wunsches nach Entlastung selten auf ambulante Unterstützungsangebote zugreifen. Zwischen der aktuellen und der künftig beabsichtigten Inanspruchnahme gibt es eine große Diskrepanz. Der Wunsch der Nicht-Nutzenden überwiegt bei den meisten Angeboten vielfach die tatsächliche Nutzung. Eine überwiegende Mehrheit von Angehörigen, die keine der acht Angebote nutzen, möchte künftig mindestens ein Angebot in Anspruch nehmen. Pflegende Angehörige von Personen mit Demenz waren belasteter und nutzen Tagespflege, Betreuungsgruppe sowie Betreuungsdienst gegenwärtig häufiger. Dies gilt auch für Angehörige von Personen mit Demenz, die gegenwärtig keine Nutzer sind. Sie beabsichtigen häufiger eine künftige Inanspruchnahme der drei genannten Angebote.Bezüglich der geschlechtsspezifischen Unterschiede wurde bestätigt, dass Männer seltener pflegen als Frauen. Zugleich beabsichtigen Männer häufiger künftig auf formelle Angebote zurückgreifen. Bei denjenigen, die bereits ein Entlastungsangebot nutzten, bestand kein Wunsch nach einer zukünftigen intensiveren Nutzung.Bezüglich der Einflussfaktoren für die gegenwärtige Nutzung des ambulanten Pflegedienstes zeigte sich, dass pflegende Angehörige, die nicht in Partnerschaft mit der pflegebedürftigen Person leben, häufiger auf den ambulanten Pflegedienst zugreifen. Die Nutzung nahm mit steigendem Pflegegrad der pflegebedürftigen Person zu. Ferner war die Nutzung häufiger bei pflegenden Angehörigen, die mit der Pflege schlechter zurechtkamen. Für die künftig beabsichtigte Nutzung hatte zum einen der niedrigere Pflegegrad und zum anderen der Wunsch nach informeller Hilfe einen signifikanten Einfluss.