The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease

The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Study Overview

• Status: Withdrawn
• Conditions: Alzheimer Disease; Sleep Apnea; Sleep Deprivation; Blood Brain Barrier Defect
• Intervention / Treatment: Diagnostic test: Diagnostic Test

Detailed Description

The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Sleep quality impairment is a known risk factor for memory impairment. There is increasing evidence of a link between measurable sleep parameters, in particular a reduction of slow waves of deep sleep in cognitive deficits. Also, breathing pauses during sleep are associated with increased daytime sleepiness and cognitive impairment. This observational study is intended to establish a possible link between subjective memory disturbances and altered sleep quality or respiratory breaks during sleep. In the run-up to this study, they performed a special MRI scan of the head and a lumbar puncture (removal of nerve water) in a different context. The aim of this imaging study and the new biomarker in brain water was to investigate the function of the blood-brain barrier that occurs in Alzheimer's disease. The results of the studies on the quality of sleep should be evaluated in the context of this study in connection with the findings of the MRI examination and lumbar puncture.

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A description of the study population is provided by DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).

Description

The eligibility criteria are defined by the study protocol from the observational study DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mild cognitive impairment; Individuals who show deficits in neuropsychological test procedures but who do not exhibit substantial problems in daily life. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.	Diagnostic test: Diagnostic Test; Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.
Dementia due to Alzheimer's disease; Individuals diagnosed with dementia due to Alzheimer's disease by relying on anamnesis, neuropsychological test results, results of MRI and biomarkers found in the cerebrospinal fluid. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.	Diagnostic test: Diagnostic Test; Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.
Healthy controls; Healthy controls recruited through public advertisement.	Diagnostic test: Diagnostic Test; Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.
Siblings of people with Alzheimer's dementia; Siblings of people with Alzheimer's dementia recruited through public advertisement	Diagnostic test: Diagnostic Test; Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.
Subjective cognitive decline; Individuals who subjectively experience cognitive decline but do not show deficits in age-, sex- and education-normed neuropsychological test results. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.	Diagnostic test: Diagnostic Test; Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marker of blood-brain dysfunction using MRI	Dynamic T1 contrast enhanced sequence using Gadovist	1 day
Markers of blood-brain dysfunction using CSF	Platelet-derived growth factor receptor-β in CSF	1 day
Sleep quality measurement	Polysomnography	2 day

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Arda Can Cetindag; Lukas Preis

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Sleep Deprivation; Cognition Disorders
• Other Study ID Numbers: BBB-Sleep

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No