A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.
The challenges with this study mainly pertained to recruiting and retention of Alzheimer’s patients, and the frequent reliance on caregivers to actively support the patients’ participation. In addition, the length of the study was to exceed one year requiring long term strategies for patient and caregiver engagement.
The pipeline of new drugs for Alzheimer’s disease can create an environment that is quite competitive for patients. In this case, the protocol had an extensive list of concomitant medications that were prohibited during the study making it more difficult to find qualified participants.