Information and Competency for Consent to Pharmacologic Clinical Trials in Alzheimer Disease: An Empirical Analysis in Patients and Family Caregivers

Summary:
This study was undertaken to evaluate (1) what information normal and Alzheimer disease (AD) participants are able to manage; (2) the correlation between the degree of competency and age, education and dementia scores, and the ability of dementia scores to predict incompetence; and (3) the capacity to retain consent-related information. To fulfil these aims, a four-point competency rating scale (1 = incompetent, 2 = marginally competent, 3 = sufficiently competent, and 4 = completely competent) was used in 70 patients (Mini-Mental State Examination [MMSE] score >9; Global Deterioration Scale score <6) and in 40 cognitively normal caregivers. Patients were divided into two subgroups (competency ratings 1 and 2 versus 3 and 4) to calculate positive and negative predictive values of MMSE and Alzheimer Disease Assessment Scale–cognitive (ADAScog) for absent/marginal competence….

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