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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04093882
Enrollment
101
Registered
2019-09-18
Start date
2019-09-12
Completion date
2021-09-30
Last updated
2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Blood Brain Barrier, Cognitive Dysfunction, Dementia

Brief summary

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.

Interventions

DIAGNOSTIC_TESTContrast agent enhanced 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.

Sponsors

Prof. Dr. med. Jochen Fiebach (Senior Physician)
CollaboratorUNKNOWN
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marker of blood-brain dysfunction using MRI1 dayDynamic T1 contrast enhanced sequence using Gadovist
Markers of blood-brain dysfunction using CSF1 dayPlatelet-derived growth factor receptor-β in CSF

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026