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

NCT04300569 | Completed

• 1 other identifier: E2006-A001-111
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Irregular Sleep Wake Rhythm Disorder

Keywords

Irregular Sleep-Wake Rhythm Disorder; Alzheimer's disease dementia; Vascular dementia; Circadian Rhythm Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Non-interventional OTHER

No intervention will be administered.

Patients and Caregivers: Overall Population

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient Participants
• Age 60 to 90 years at time of informed consent
• 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
• 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.
• 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
• Frequency of complaint of sleep and wake fragmentation greater than equal to (\>=) 3 days per Week
• Duration of complaint of sleep and wake fragmentation \>=3 Months
• 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
• Has a caregiver who is also a participant in this study and who meets the eligibility criteria below
• 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
• Age 18 years or older at the time of consent
• 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:
• Has a documented diagnosis of AD-D on the basis of the NIA-AA diagnostic guidelines and/or VaD per NINDS-AIREN criteria
• 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

You may not qualify if:

• Patient Participants
• A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
• 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
• The person for whom they care is a non-interviewed patient with any of the following:
• 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
• A diagnosis of a Lewy body dementia (including Parkinson's disease dementia or dementia with Lewy bodies)
• 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
• History of drug or alcohol dependency or abuse within approximately the last 2 years
• Psychotic disorder(s) or unstable recurrent affective disorder(s) as evident by use of antipsychotic medications within approximately the last 2 years
• History of drug or alcohol dependency or abuse within approximately the last 2 years
• Current regular use (greater than \[\>\]2) times per week) of medication prescribed to treat insomnia (either approved or off-label)

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (6)

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

Pacific Research Network Inc

San Diego, California, 92103, United States

Location

Miami Jewish Health Systems

Miami, Florida, 33137, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Abington Neurologic Associate

Willow Grove, Pennsylvania, 19090, United States

Location

MeSH Terms

Conditions

Dementia, Vascular; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Chronobiology Disorders; Dyssomnias; Sleep Wake Disorders; Occupational Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 9, 2020
• Study Start: July 9, 2020
• Primary Completion: September 7, 2020
• Study Completion: September 7, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (6)