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Background: Sleep‐wake disturbances appear early in the course of Alzheimer's disease (AD) and other dementias and are not uncommonly associated with disruption in circadian rhythms, such as Irregular Sleep‐Wake Rhythm Disorder (ISWRD; ICD‐10 code G47‐23). ISWRD is also associated with behavioural and functional symptoms. The objective of this study (E2006‐A001‐111; NCT04300569) was to identify signs and symptoms of ISWRD important to patients and caregivers of patients with dementia and ISWRD. The data informed a novel questionnaire, filling a measurement gap as no questionnaires specific to ISWRD in the AD population are available. Method: This cross‐sectional, qualitative, non‐interventional, telephone study interviewed patients and their caregivers. Caregivers were interviewed apart from the patient; patients were interviewed with caregivers present. All participants were from the US; data were collected in English and Spanish. Interview transcripts were analysed using ATLAS.ti software. Result: 15 patient/caregiver dyads and 5 caregiver‐only subjects were interviewed. For the patient group (n=20; 5 not interviewed), mean age was 79.0 (8.3)y and 75% were male. For the caregiver group (n=20), mean age was 67.5 (14.5)y and 20% were male. Both caregivers and patients noted fragmented nighttime and daytime sleep‐wake patterns, but also reported functional consequences of ISWRD. Nighttime examples included waking, wandering, and refusing to go back to sleep. Daytime examples included falling asleep at inappropriate places; appearing sleepy; losing concentration due to sleepiness; sleepiness interfering with personal care and leisure activities; needing to postpone, change, or avoid activities due to sleepiness; adverse emotional impacts, and sundowning. Few differences in terms, or their meaning, were identified between language of data collection. Based on the differing quality of patient and caregiver reports, the potential for patient anosognosia, and the ability of caregivers to observe signs and behaviours, the data suggested a caregiver‐completed observer‐reported outcome (ObsRO) measure is most appropriate for ISWRD evaluation. Conclusion: Concepts reported by patients and caregivers uncovered ISWRD observations and functional consequences appropriate for a novel ObsRO measure that can be used in future studies of ISWRD. Support: Eisai Inc. [ABSTRACT FROM AUTHOR]