Management of sleep disturbance related to Alzheimer disease and dementia: An updated review of ClinicalTrials.gov

Abstract

Sleep disturbances are prevalent and commonly associated with Alzheimer disease (AD) and other forms of dementia, significantly impacting the quality of life for patients and their caregivers. These disturbances not only exacerbate cognitive decline but also contribute to the overall progression of neurodegenerative diseases. This review highlights the importance of managing sleep disturbances in patients with AD and dementia by analyzing completed clinical trials on this topic. A comprehensive search of the ClinicalTrials.gov database was performed on July 21, 2024, to identify all relevant clinical trials evaluating the efficacy of interventions for managing sleep disturbances in this population. Trials were included if they focused specifically on interventions for sleep disturbances in patients diagnosed with AD or dementia, were completed, and had results available. A total of 9 interventional and completed clinical trials related to sleep disturbance and AD were identified, involving 1139 participants. Three of the studies were nonpharmacological interventions, while 6 were pharmacological. Four studies were phase 2 clinical trials, and 1 was phase 3; the remaining were categorized as nonpharmacological. All studies were completed and had reported results. This review identifies a limited number of clinical trials addressing sleep disturbances in AD and dementia using either pharmacological or nonpharmacological interventions. Further clinical trials are recommended due to the impact of sleep disturbances on the quality of life for both patients and caregivers.

Keywords: Alzheimer disease; clinical trials; dementia; pharmacotherapy; sleep disturbance.

Figure 1.

Flow diagram of trial selection process (updated from ClinicalTrials.gov July 21, 2024.).