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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04096261
• Other study ID #: BBB-Sleep
• Status: Withdrawn
• Start date: September 12, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Blood Brain Barrier Defect
• Cognition Disorders
• Sleep Apnea
• Sleep Deprivation

Intervention

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.

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Arda Can Cetindag, Lukas Preis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marker of blood-brain dysfunction using MRI	Dynamic T1 contrast enhanced sequence using Gadovist	1 day
Primary	Markers of blood-brain dysfunction using CSF	Platelet-derived growth factor receptor-ß in CSF	1 day
Primary	Sleep quality measurement	Polysomnography	2 day