TABLE 4.

Issues with eligibility criteria of clinical trials and recommendations

Issue/criterion	Recommendations
Overarching issues
‐Race and ethnicity often were not reported ‐Current race/ethnicity definitions not globally suitable ‐It is unclear how many diverse patients are invited, screened, and excluded ‐It is unclear which criteria lead to exclusion ‐Criteria from phase II copied to and expanded on in phase III	‐Improve reporting ‐Critically examine and improve definitions of race/ethnicity ‐Improve reporting ‐Improve reporting ‐Revisit/revise all criteria in moving from phase II to phase III
Criteria related to medical conditions
‐Imprecise/unspecific definitions of medical conditions ‐Variation in cut‐offs for specific medical conditions ‐It is unclear if race corrections should be used or not ‐Exclusion of all patients with a medical condition regardless of past/present health status ‐Questionable safety of drugs for patients with medical conditions due to exclusion	‐Use validated, internationally recognized clinical classifications (of disease staging) ‐Organize expert consensus meetings to determine appropriate cut‐offs in AD research ‐Organize expert consensus meetings to determine whether and when to apply race corrections ‐Include more patients who can safely participate, for example, persons living with HIV who are medically stable and have a non‐detectable viral load ‐Use expansion cohorts to study safety
Criteria related to study procedures
‐Language fluency as a barrier to participation ‐Lower educated individuals often excluded ‐Risk of compliance stereotyping if “likely to complete” is not defined ‐Caregiver attendance as a barrier to participation ‐Written informed consent as a barrier in persons with limited literacy/education	‐Allow fluency in any language if adapted materials and staff speaking that language are available ‐Allow persons with a work history consistent with no intellectual disabilities (ID) to participate ‐Investigate other ways to screen for ID ‐Define “likely to complete” before trial ‐Allow others to accompany patient on subset of visits ‐Plan appointments outside business hours ‐Explore remote interviewing options ‐Explore alternatives for written informed consent, such as video informed consent
Criteria related to neurocognitive and neuropsychiatric measures
‐MMSE is unsuitable for diverse populations ‐CDR may be biased due to cultural differences	‐Consider alternative, more widely applicable tests ‐Use different MMSE cut‐offs depending on education and other relevant variables ‐Consider adaptations to the instrument/questions ‐Provide additional training to staff

Abbreviations: AD, Alzheimer's disease; CDR, Clinical Dementia Rating; MMSE, Mini‐Mental State Examination.