Findings
Digital technologies face challenges across scientific, clinical, technological, business, ethical, and regulatory domains.
Current testing paradigms are inadequate for identifying meaningful changes in early-stage Alzheimer’s disease.
Complex digital tools may not be suitable for all trial participants due to varying technology, motor, or cognitive skills.
Ethical issues such as privacy, data sharing policies, and informed consent are significant concerns.
The regulatory path for digital medical devices is unclear and needs further development.

Recommendations
Develop more sensitive and specific diagnostic tools for early-stage Alzheimer’s disease.
Create adaptable and user-friendly digital tools suitable for diverse populations.
Address ethical concerns by establishing clear privacy and data sharing policies.
Engage with regulatory bodies early to understand the regulatory landscape.
Integrate digital tools into clinical trials alongside traditional measures to advance the field.

Regulatory Considerations
The regulatory path for digital medical devices is currently unclear and needs clarification.
Developers should follow design control methods and ensure compliance with relevant regulations.
Early engagement with regulatory agencies is recommended to speed up development and approval processes.