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

NCT04096261 | Withdrawn

• 1 other identifier: BBB-Sleep
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Brain Barrier Defect; Sleep Deprivation; Sleep Apnea; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Healthy controls

Healthy controls recruited through public advertisement.

Diagnostic Test: Diagnostic Test

Siblings of people with Alzheimer's dementia

Siblings of people with Alzheimer's dementia recruited through public advertisement

Diagnostic Test: Diagnostic Test

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

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

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

Interventions

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; Healthy controls; Mild cognitive impairment; Siblings of people with Alzheimer's dementia; Subjective cognitive decline

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Arda Can Cetindag: collaborator
• Lukas Preis: collaborator

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebro-spinal fluid

MeSH Terms

Conditions

Sleep Deprivation; Sleep Apnea Syndromes; Alzheimer Disease

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 19, 2019
• Study Start: September 12, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)