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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT04093882
• Collaborator: Prof. Dr. med. Jochen Fiebach (Senior Physician) (Other)
• Enrollment: 101
• Location: 1
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Brain Barrier; Alzheimer Disease; Cognitive Dysfunction; Dementia	Diagnostic Test: Contrast agent enhanced MRI using Gadovist

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 101 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
• Actual Study Start Date: Sep 12, 2019
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Cognitive normal Individuals who do not show clinical or neuropsychological deficits.	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.
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.	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.
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 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.

Outcome Measures

Primary Outcome Measures

1. Marker of blood-brain dysfunction using MRI [1 day]

   Dynamic T1 contrast enhanced sequence using Gadovist

2. Markers of blood-brain dysfunction using CSF [1 day]

   Platelet-derived growth factor receptor-β in CSF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

• Charite University, Berlin, Germany
• Prof. Dr. med. Jochen Fiebach (Senior Physician)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oliver Peters, MD, Prof. dr. med. (Consultant Psychiatrist), Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04093882
• Other Study ID Numbers: BHSkog
• First Posted: Sep 18, 2019
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Nov 11, 2021