- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04096261
The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Kontakter och platser
Studieorter
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Berlin, Tyskland, 10117
- Charité Universitätsmedizin Berlin
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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.
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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: 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: 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: 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: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Marker of blood-brain dysfunction using MRI
Tidsram: 1 day
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Dynamic T1 contrast enhanced sequence using Gadovist
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1 day
|
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Markers of blood-brain dysfunction using CSF
Tidsram: 1 day
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Platelet-derived growth factor receptor-β in CSF
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1 day
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Sleep quality measurement
Tidsram: 2 day
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Polysomnography
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2 day
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BBB-Sleep
Plan för individuella deltagardata (IPD)
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