A systematic search was conducted in 4 databases for relevant literature: PubMed, Web of Science, Scopus, and EBSCOhost, from database inception to January 31, 2024. Keywords included MeSH (Medical Subject Headings) terms and synonyms as follows: “living lab” AND “dementia” AND “barrier” OR “obstacles” OR “facilitators” OR “enablers.” Details of the search strategy, including specific search strings and filters used, are available in Multimedia Appendix 1.

Studies were included if they met all of the following criteria, namely (1) reporting findings within an LL approach (with consideration for multimethod approaches, user engagement, multistakeholder participation, real-life settings, and cocreation); (2) piloting initiatives related to dementia or cognitive decline; (3) randomized controlled trials, observational studies, qualitative studies, mixed methods studies, intervention studies, implementation science studies, case studies, and systematic reviews or meta-analyses or scoping reviews; and (4) publications written in English, Spanish, or Portuguese.

Studies were excluded if they met any of the following criteria, namely (1) those not addressing the topic of barriers and facilitators of piloting initiatives; (2) those describing or analyzing the technical parameters of a digital solution; (3) those comprising samples with cognitive problems not directly related to dementia or degenerative cognitive impairment (eg, aphasia); and (4) study protocols, theoretical papers, conceptual papers, and position papers.

After retrieving manuscripts, duplicates were removed using EndNote software (v21; Clarivate Analytics). Subsequently, 2 authors (SA and ND) independently assessed the titles and abstracts of all potentially relevant articles. The full texts of these articles were then meticulously reviewed to determine final eligibility based on predefined inclusion and exclusion criteria. Any discrepancies were resolved through consensus with a third reviewer (TF), who conducted an independent analysis of such manuscripts. Additionally, reference lists of the included articles were screened to identify supplementary relevant studies.

To ensure consistency in data extraction, an Excel spreadsheet (Office 21, v.2405; Microsoft Corporation) was created to document key study information, including author details, publication year, country, study design, sample size, participant type (eg, people with dementia, professionals, caregivers, and family members), and a brief description of the piloted initiatives. Extracted data also included key facilitators and barriers reported in each study.

A narrative synthesis was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. The synthesis followed two sequential analytical stages:

Two reviewers (SA and ND) independently performed the coding using NVivo software (v.14.23.3; Lumivero LLC). Regular meetings were held to discuss coding discrepancies and reach consensus, with a third reviewer (TF) available for arbitration when needed.

Following an iterative review of the extracted data and initial coding, two overarching themes were identified: (1) organizational and operational issues and (2) ethical and legal considerations. Each of these themes was further divided into subtopics that encompassed both barriers and facilitators [22]. Themes and subtopics were refined and organized into a final framework of facilitators and barriers.

A formal risk of bias assessment was not conducted, as the included studies primarily focused on methodological and participatory approaches for engaging people living with dementia under an LL approach rather than interventional studies. However, to ensure transparency, a completed PRISMA checklist is provided as supplementary material in Checklist 1. This review was registered in PROSPERO (CDR42024514481).

The initial search resulted in a total of 119 publications. After duplicate removal and full-text analysis, 15 met the inclusion criteria (Figure 1).

Findings were synthesized narratively through content and thematic analysis, according to the predefined analytical framework. Two overarching themes emerged, which were (1) organizational and operational issues and (2) ethical and legal considerations, each comprising several subthemes that captured both facilitators and barriers. Of the 15 studies [18,23-36], engaging people living with dementia was the most frequently reported subtheme (14 studies) [18,23-31,33-36], followed by research design and evaluation methods (12 studies) [23-31,33-36], co-design and testing phases (12 studies) [23-31,34-36], and LL governance (10 studies) [18,23,26,28-31,33-35].

The studies were mainly qualitative (n=10) [18,23-25,28-32,35] and mixed methods (n=5) [26,27,33,34,36] (Multimedia Appendix 2). The reviewed articles were all from Europe, with the exception of 1 article from Canada, that is, Pigot and Giroux [23]. Facilitators and barriers were presented below by themes and subtopics. Multimedia Appendix 2 provides an overview of the included studies, while Table 1 summarizes facilitators and barriers by theme.

Within the theme of organizational and operational aspects, 14 [18,23-31,33-36] out of 15 studies [18,23-36] identified various facilitators and barriers in piloting dementia initiatives using the LL approach. Four subthemes were identified within this theme: engaging people living with dementia, research design and evaluation methods, co-design and testing phases, and LL governance.

Eight [18,24,26,27,29-32] out of 15 studies [18,23-36] identified ethical and legal facilitators and barriers relevant to a dementia-focused LL approach. These findings were categorized into 2 main topics: informed consent procedures and regulatory aspects. While all studies discussed facilitators and/or barriers related to informed consent procedures, only 4 of them [18,27,29,31] addressed regulatory aspects (refer to Multimedia Appendix 2 for further details).

This systematic review identified key facilitators and barriers that influence the successful piloting of dementia initiatives within an LL approach. Two overarching themes emerged, namely “Organizational and Operational Issues” and “Ethical and Legal Considerations,” each encompassing a series of recurrent subthemes across the 15 included studies [18,23-36]. Overall, the findings show that LLs hold significant potential to support innovation in dementia care, but their effectiveness depends heavily on adapting methodological, ethical, and governance procedures to the specific needs and vulnerabilities of people living with dementia.

Consistent with previous literature, the studies highlighted that engaging people living with dementia requires approaches that accommodate fluctuating cognitive abilities, promote familiarity, and reduce cognitive burden [19,37,38]. Facilitators such as friendly atmospheres, familiar settings, accessible communication formats, and the involvement of caregivers and professionals emerged as crucial to fostering meaningful engagement. These findings illustrate the inherent complexity of piloting solutions with this population, reinforcing the need for tailored, adaptable, and iterative strategies. They also underscore the importance of ethical awareness and safeguarding the rights and well-being of people living with dementia while ensuring that their perspectives are integrated throughout the co-design process.

Based on the analysis of barriers and facilitators, 3 core aspects emerge as central to understanding the functioning of LLs in dementia care: the target population features, the LL ecosystem, and the LL framework gaps.

This dimension encompasses the unique needs and challenges faced by people living with dementia, including aspects that influence their participation, engagement, and adherence to the cocreation and testing processes.

The studies showed that users’ heterogeneous and fluctuating cognitive symptoms create significant challenges from the earliest stages of the innovation process. These fluctuations affect communication, emotional stability, and the ability to engage with tasks, requiring highly flexible planning and individualized support [39-42].

Aspects related to communication processes (eg, accessible communication, native language, written and oral information, visual aids, regular reminders, and managing information load), flexible and adapted assessment methods and iteration phases, and familiar settings and people, and consistent team members are essential considerations to handle the unpredictable nature of dementia. Addressing these challenges often requires involving proxies (eg, caregivers and relatives), which extends the time needed for the process and may increase communication challenges and stakeholders’ differing perspectives. These consequences ultimately influence project governance, sustainability, and the overall pace of development within LLs [38,43,44].

Another key aspect concerns the perceived benefits of the initiatives. Several studies emphasized that people living with dementia and their caregivers are more likely to accept and use a technology or intervention when they perceive clear, immediate value [18,28,31,33,36]. This aligns with previous research that documented that technology is either not accepted at all or is quickly abandoned when users do not perceive an immediate benefit [45-47]. Ensuring simple, intuitive interfaces and avoiding stigmatizing features (eg, making solutions too discreet or discouraging their use within social circles) is therefore essential. Failing to address these factors may lead to user frustration and a refusal to engage or discontinuation of use.

At the ecosystem level, the findings highlight the importance of establishing strong communication flows and working on nurturing the strategic alliances. While the quadruple helix approach provides a solid basis for multiactor collaboration, many studies emphasize the need to expand beyond traditional stakeholders to include society, the media, and local communities [48-52]. This could create more opportunities for digital innovation, diversify funding sources, and contribute to the sustainability of the LL. Sustainability emerged as a recurring challenge, with several studies identifying resource instability and limited long-term planning as barriers to continuity [18,31,33].

Some authors have proposed a “mixed-economy” approach, where both state and private funding support the innovation process in social care [18,45,53]. This approach could be particularly useful in promoting the sustainability of LLs focused on innovation in dementia care.

Another key point is the establishment of a clear goal and shared vision for the LL. The studies reviewed strongly emphasize that LL success requires a clear goal that integrates reliability, real-world benefit, and the well-being of the LL team members. Communication is central to achieving this. It allows collaboration, builds trust, and fosters a sense of belonging. Attention must be given to all stages, from preimplementation, ongoing activities, and postimplementation. Notably, the postimplementation phase appears particularly neglected, with limited evidence on long-term monitoring, communication, and impact assessment (eg, reports, communication, and long-term impact assessment) [54-56]. This gap raises concerns about whether solutions remain relevant and functional after initial deployment, given the progressive nature of dementia [19,43,57].

In dementia care, especially with digital solutions, ongoing monitoring is crucial. Since dementia is a progressive neurodegenerative disorder, adherence to digital solutions will be affected by the disease’s progression. Understanding these factors is vital to ensure that digital solutions effectively support the quality of life of people living with dementia and their caregivers, and therefore, should be a central concern of LL activity. Without this focus, LL risks introducing products that do not meet their intended purpose or do not provide real benefit.

As a relatively new approach, LLs still lack a well-defined regulatory structure. The absence of standardized guidelines leads to inconsistencies across countries and sectors, creating challenges in legal, ethical, and operational domains. This includes heterogeneity in data protection requirements, intellectual property procedures, and ethical oversight mechanisms. The limited dissemination of national dementia strategies, with less than a quarter of countries having them in place, further complicates the development of consistent standards, particularly in these populations [58].

Ethical challenges represent a core concern, particularly regarding informed consent and data protection [16,45,59,60]. Cognitive decline complicates the assessment of consent capacity and increases the need for sensitive, adaptive consent procedures. Innovative approaches such as “rolling consent” or interactive consent forms, ensuring that participants are continuously informed of their rights and can withdraw from studies at any time, fostering trust and ensuring participant safety. Privacy concerns, especially in data-rich environments such as LLs, where monitoring and data collection occur in real-life settings (including homes, hospitals, and nursing homes), further complicate the ethical management of these activities. This complexity underscores the need for robust ethical and legal regulations for dementia-focused LLs.

Mechanisms such as ethical review boards, certification authorities (eg, ENoLL), and standard contractual models can support the establishment of responsible LL operations. Strengthening these structures is critical to fostering trust, enhancing participation, and enabling LLs to function effectively in dementia-focused contexts.

Based on the results of this study, we have established some recommendations for piloting dementia initiatives (or on cognitive impairment) using an LL approach, providing a practical overview of the findings. The proposed guidelines are organized according to the topics identified in this systematic review (Table 2).

By considering these specific recommendations, LLs can improve their functioning and tackle common challenges in piloting dementia initiatives. Also, these guidelines can contribute to improving practices and to fostering sustainable and efficient innovation processes. By covering a broad range of aspects that include not only user and community involvement, but also research, governance, and ethical and regulatory considerations, these guidelines provide practical guidance for academia (research), policymakers, industry, and health care agents. For example, integrating iterative user feedback and ethical reviews can help tailor initiatives more effectively; furthermore, establishing clear metrics for evaluating the initiatives’ impact will be crucial for assessing their effectiveness. At the ultimate end, these guidelines have the potential to enhance the impact of the LL approach in the dementia field, leading to improved health outcomes and quality of life of those affected, ensuring that innovation processes meet users’ needs effectively.

This systematic review is subject to certain limitations. First, despite a comprehensive search strategy across 4 major databases, relevant studies may have been overlooked due to language restrictions (English, Spanish, and Portuguese), and the still-emerging nature of research on dementia-focused LLs. These factors may have contributed to publication bias and limited the diversity of included contexts.

Another limitation of this study pertains to the thematic analysis of the findings, which is susceptible to the influence of the authors’ backgrounds and understanding of the topic. To strengthen trustworthiness, 2 authors independently coded and discussed emerging categories, and interpretations were refined through consensus and alignment with existing literature and the review’s guiding question.

A formal risk of bias assessment was not conducted, as this review focused on synthesizing facilitators and barriers rather than evaluating intervention effects. While this may limit comparability across studies, a structured appraisal was not applicable given the descriptive and exploratory nature of the evidence. Future reviews should incorporate formal bias assessments when suitable tools for qualitative and mixed methods LL research become available.

Finally, the geographical distribution of the publications is predominantly from European Union countries. Out of 15 studies included [18,23-36], only 1 was outside Europe, which could limit the generalization of the findings and reduce the applicability of the conclusions to other contexts. Further research is needed to explore how national dementia strategies, funding mechanisms, and societal attitudes influence LL implementation beyond European contexts.

In conclusion, this systematic review identifies key aspects for successfully piloting dementia initiatives within an LL framework. A comprehensive and strategically planned approach is essential to effectively address real-world needs. It encompasses a user-centered design that accounts for the cognitive limitations of people living with dementia and balances the interests of stakeholders. Equally important is the development of robust governance models that foster collaboration, ensure smooth communication, promote extensive networking, and secure consistent and long-term funding, all supported by clear ethical guidelines and regulatory standards. By establishing equilibrium among stakeholders’ interests and ensuring adaptability, LLs can serve as effective platforms for driving innovation in dementia care.