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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093882
• Other study ID #: BHSkog
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Blood Brain Barrier
• Cognitive Dysfunction
• Dementia

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