PRACTICAL IMPLICATIONS OF SERIAL COGNITIVE EVALUATION FOR RANDOMISED CONTROLLED TRIALS INVESTIGATING PRECLINICAL ALZHEIMER'S DISEASE
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Keywords
Alzheimer’s disease; Practice effects; Cognition; Clinical trials; Serial assessment; Preclinical Alzheimer’s disease; Neuropsychology
Abstract
An Overview Practice effects are a common attribute observed in almost all standard cognitive tasks. When they manifest repeatedly during serial assessments, they frequently function as significant confounding variables in clinical trials. Implementing Methods: In this review, we provide an exhaustive synthesis of the evidence indicating that improvements in neuropsychological test performance scores ascribed to practice effects are, in fact, spurious adjustments introduced by serial testing in clinical trials. These gains are identified and highlighted in elderly individuals without cognitive impairments, and an effect size of 0.25 is estimated for composite cognitive measures administered three times over a period of six to twelve months to geriatric populations. As findings, three complementary strategies for mitigating the effects of practice were discovered. To address the impact of task familiarity, the following measures were implemented: (1) pre-baseline massed practice; (2) assessments intended to maximise interitem interference while minimising advances driven by strategy; and (3) appropriately matched alternate forms. Discussion: The consequences of improvements linked to the practice effect, which may lead to errors of type 1 or type 2 in clinical trials, have been brought to the forefront and comprehended more thoroughly. Through the effective supervision of practice effects, it is possible to reduce the likelihood of misinterpreting the outcomes of clinical trials and eradicate a significant source of error.
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