The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease

This study attempts to replicate the findings published in Nature Medicine by Nation and colleagues (2019). By using a large observational cohort (DZNE - Longitudinal Cognitive Impairment and Dementia Study; DELCODE) consisting of cognitively healthy individuals, individuals with subjective cognitive decline, mild cognitive impairment, and dementia due to Alzheimer's disease, an association between the blood-brain barrier and cognitive dysfunction is investigated. The integrity of the blood-brain barrier is investigated by using a novel MRI protocol as well as a novel biomarker in the cerebrospinal fluid.

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Key information

Conditions

Blood Brain Barrier Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥ 50 years with neuropsychologically confirmed no cognitive dysfunction, mild cognitive impairment or mild dementia

Exclusion cirteria:

no current or prior history of any neurological or psychiatric condition, which might affect cognitive function
no neurodegenerative disease other than AD
specifically no extensive vascular white matter dementia or vascular dementia

Treatment and study plan

Contrast agent enhanced MRI using Gadovist

Diagnostic Test

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.

Primary outcomes

Marker of blood-brain dysfunction using MRI

Time frame: 1 day

Dynamic T1 contrast enhanced sequence using Gadovist
Markers of blood-brain dysfunction using CSF

Time frame: 1 day

Platelet-derived growth factor receptor-β in CSF

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

Prof. Dr. med. Jochen Fiebach (Senior Physician)

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 18, 2019
Registry last updated: Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed