Trial results for a pilot study on napping, sleep, and cognitive decline in Alzheimer's Disease were posted on 2025-11-14. The study, which aimed to test a non-pharmacological sleep intervention, was terminated early after enrolling a total of 15 participants.
Background
Alzheimer's Disease and mild cognitive impairment are conditions characterized by progressive cognitive decline. Research continues to explore non-pharmacological interventions that could potentially improve cognitive function. This particular study aimed to investigate the feasibility and preliminary effects of a behavioral treatment program focused on improving the 24-hour sleep-wake cycle in individuals with mild cognitive impairment or mild Alzheimer's disease, utilizing bright light therapy and a modified cognitive behavioral therapy for insomnia.
Trial design
This pilot study, designated as Phase NA, was terminated with an overall enrollment of 15 participants. The trial focused on conditions including Sleep, Alzheimer Disease, Cognitive Impairment, Aging, and CBT. The study aimed to develop and pilot test a non-pharmacological (behavioral) treatment program designed to improve cognition by addressing the 24-hour sleep-wake cycle. This program incorporated bright light therapy and a modified cognitive behavioral therapy for insomnia. Participants were allocated to either a Sleep Intervention group or a Placebo Intervention group, though the study was terminated before reporting on its primary objectives.
Key results
The study reported on participant enrollment prior to its termination:
- In the Sleep Intervention group, 8 participants were enrolled.
- In the Placebo Intervention group, 7 participants were enrolled.
No primary outcome measurements or key analyses were reported for this terminated trial.
What this means
Given the termination of the study and the absence of reported primary outcome measurements or key analyses, no conclusions can be drawn regarding the efficacy or preliminary effects of the non-pharmacological sleep intervention on cognition in individuals with mild cognitive impairment or mild Alzheimer's disease. The data available primarily reflects the enrollment figures at the time of termination.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03256539, titled "Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease", were posted on 2025-11-14 on clinicaltrials.gov.