An Example Randomized Controlled Trial Design: The Case of Body Weight and Cognitive Impairments.
An example study design is to compare patients with CI who are underweight or experience body weight loss with patients who are overweight or obese. This 18–24 month intervention compares commonly used AChEI, which as a class have been shown to be beneficial for cognition and contribute to body weight loss versus a combined therapy of AChEI plus a body weight enhancer. We hypothesize that patients randomized to AChEI + body weight enhancer will maintain cognitive function and body weight, and have less cognitive decline, and behavioral and psychological symptoms, compared to those not receiving combined therapy.