Abstract
AbstractBackgroundWith a lifespan buildup of amyloid beta in individuals with Down Syndrome (DS), comes the opportunity to study Alzheimer’s disease (AD) related pathological processes in potentially smaller sample sizes and shorter duration trials.MethodThere are multiple differences between these groups that require attention in designing investigational trials in the DS population. Primary is that DS participants constitute a vulnerable population.ResultThere is a wide range of intellectual disability (ID), and not all participants will have similar understanding of the informed consent/ assent process. Respecting the individuals perspective will be necessary to ensure open communication and build trust. These differences in ID translate into cognitive capacity which reflects upon reaction time, verbal working memory and mental flexibility. The variation in ID applies to mental health concerns as anxiety over novel situations and depression over life/environmental changes are frequent and require accommodation by both the family and the trial site. While many physical problems associated with DS are corrected in childhood, more problems arise during succeeding decades: obstructive sleep apnea, epilepsy (bimodal occurrences), poor visual and/or auditory acuity, and heightened immune responses are some co‐morbidities which will need to be addressed.ConclusionMore overwhelmingly is a need for the investigational site to build a strong, long‐term trusting relationship with DS individuals and their families or caregivers. Investigators will need to encourage DS parents or their study partners to take an active role in preparing and soothing the participants while allowing some degree of autonomy to boost confidence and increase tolerance to clinical assessments.
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