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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04093882
Other study ID # BHSkog
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 12, 2019
Est. completion date September 30, 2021

Study information

Verified date November 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Contrast 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.

Locations

Country Name City State
Germany Charité Universitätsmedizin Berlin Berlin

Sponsors (2)

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

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
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