A Study to Determine the Signs and Symptoms That Impact Daily Life of Participants With Irregular Sleep-Wake Rhythm Disorder

A Prospective, Non-Interventional Study to Determine Signs and Symptoms That Impact Daily Life of Patients With Irregular Sleep-Wake Rhythm Disorder and Their Caregivers

The primary purpose of this study is to determine the signs and symptoms of irregular sleep-wake rhythm disorder (ISWRD) that are important to patients and caregivers of patients with Alzheimer's disease dementia (AD-D), AD-D with cerebrovascular disease (CVD), and/or vascular dementia (VaD) and ISWRD, and to draft an instrument or instruments to assess them.

Study Overview

• Status: Completed
• Conditions: Irregular Sleep Wake Rhythm Disorder
• Intervention / Treatment: Other: Non-interventional

Detailed Description

The study is comprised of an interview with patients and caregivers to determine the signs and symptoms of ISWRD that are important to patients and caregivers of patients.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research
    • San Diego, California, United States, 92103
      • Pacific Research Network Inc
  • Florida
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Miami Lakes, Florida, United States, 33014
      • Panax Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Pennsylvania
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Neurologic Associate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with AD-D, AD-D with CVD and/or VaD and ISWRD and caregivers of patients.

Description

Inclusion Criteria:

Patient Participants

1. Age 60 to 90 years at time of informed consent
2. Documentation of diagnosis of AD-D on the basis of the clinical criteria of the National Institute on Aging/Alzheimer's Association (NIA-AA) diagnostic guidelines and/or VaD on the basis of the National Institute of Neurological Disorders and Stroke (NINDS) and the Association Internationale pour la Recherche et l'Enseignement en Neurosciences (AIREN) criteria, and AD-D with CVD on the basis of NINDS-AIREN criteria
3. If the Mini Mental State Examination (MMSE) is conducted (mandatory for clinic visits only) or is available within the past 3 months (all patient participants), MMSE 10 to 26. Note: For all patient participants who undergo a clinic visit, an MMSE must be conducted unless this has been assessed within the past 3 months and the score is available. No MMSE will be conducted during telephone visits, but if a recent MMSE is available, that is, within the past 3 months, that MMSE must be assessed for eligibility.

4. Meets criteria for Circadian Rhythm Sleep Disorder, Irregular Sleep-Wake Type (Diagnostic and Statistical Manual of Mental Disorders - 5th edition [DSM-5]) and the 10th revision of the International Classification of Diseases (ICD-10), as follows: Complaint by the patient or caregiver that the patient has difficulty sleeping during the night and/or has excessive daytime sleepiness associated with multiple irregular sleep bouts during a 24-hour period

   1. Frequency of complaint of sleep and wake fragmentation greater than equal to (>=) 3 days per Week
   2. Duration of complaint of sleep and wake fragmentation >=3 Months
5. If currently taking medications that are used to treat behaviors associated with ISWRD, such as antipsychotic medications or trazodone, the dose must be stable for at least 1 Month
6. Has a caregiver who is also a participant in this study and who meets the eligibility criteria below
7. Is able to speak and understand English or Spanish at a level sufficient to participate in the study interviews, according to the investigator's judgement

Caregivers

1. Age 18 years or older at the time of consent

2. Where the patient is not a study participant (that is, is a non-interviewed patient): The caregiver currently lives with a patient who meets the following criteria:

   1. Has a documented diagnosis of AD-D on the basis of the NIA-AA diagnostic guidelines and/or VaD per NINDS-AIREN criteria
   2. Meets criteria for Circadian Rhythm Sleep Disorder, Irregular Sleep-Wake Type (DSM-5) and the 10th revision of the International Classification of Diseases (ICD-10), as follows: Complaint by the patient or caregiver that the patient has difficulty sleeping during the night and/or has excessive daytime sleepiness associated with multiple irregular sleep bouts during a 24-hour period
3. Is able and willing to provide informed consent or assent.
4. If the MMSE is conducted for the non-interviewed patient (mandatory for clinic visits only) or has been assessed during the past 3 months (all non-interviewed patients), MMSE 10 to 26 Note: For all non-interviewed patients who undergo a clinic visit, the MMSE must be checked for eligibility. The MMSE will be conducted at the clinic visit unless this has been assessed within the past 3 months and the score is available. No MMSE will be conducted during telephone visits, but if a recent MMSE is available,that is, within the past 3 months, that MMSE must be assessed for eligibility.)
5. Is sufficiently familiar (as determined by the investigator) with the patient participant or non-interviewed patient to provide accurate data. The caregiver must share the patient's domicile for an average of at least 5 days and 5 overnights per week for at least the past 3 months
6. Able to speak and understand English or Spanish at a level sufficient to participate in the study interviews, according to the investigator's judgement
7. Willing to have the interview audio recorded

Exclusion Criteria:

Patient Participants

1. A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
2. A diagnosis of moderate or severe obstructive sleep apnea (OSA), or current use of continuous positive airway pressure (CPAP) even if mild OSA, restless legs syndrome or any other disorder except ISWRD that is likely to impact sleep and interfere with the assessment of ISWRD in the opinion of the investigator

Caregivers

1. The person for whom they care is a non-interviewed patient with any of the following:

   1. A diagnosis of OSA, restless legs syndrome or any other disorder except ISWRD that is likely to impact sleep and interfere with the assessment of ISWRD in the opinion of the investigator
   2. A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
   3. Evidence of current clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) or any psychiatric disorder other than dementia, that in the opinion of the clinic site investigator could interfere with the assessment of ISWRD
   4. History of drug or alcohol dependency or abuse within approximately the last 2 years
2. Psychotic disorder(s) or unstable recurrent affective disorder(s) as evident by use of antipsychotic medications within approximately the last 2 years
3. History of drug or alcohol dependency or abuse within approximately the last 2 years
4. Current regular use (greater than [>]2) times per week) of medication prescribed to treat insomnia (either approved or off-label)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients and Caregivers: Overall Population; Overall population of this study will include both patients with ISWRD associated with AD-D, AD-D with CVD, and/or VaD, and care givers of patients. Patients and caregivers will undergo all study procedures. Caregivers may care either for a patients who undergo all study procedure (including interview) as well for patients who do not undergo any study procedures but give consent or assent for the use of their medical records in the study ("non-interviewed patient").

Other: Non-interventional; No intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of Scale for the Assessment of the Signs and Symptoms of Irregular Sleep-wake Rhythm Disorder (ISWRD) Based on Interview Data	Development of scale for the assessment of the signs and symptoms of ISWRD based on interview data of participants using ATLAS ti Coding software will be reported. This study will determine the sleep-wake symptoms and signs that are the most relevant and important from the patient and caregiver perspectives.	Up to approximately 3 weeks

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): September 7, 2020
• Study Completion (Actual): September 7, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Vascular dementia; Irregular Sleep-Wake Rhythm Disorder; Alzheimer's disease dementia; Circadian Rhythm Sleep Disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: E2006-A001-111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on the Eisai website http://eisaiclinicaltrials.com/.