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

Sponsors

Lead Sponsor: Charite University, Berlin, Germany

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

Source Charite University, Berlin, Germany
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.

Overall Status Recruiting
Start Date 2019-09-12
Completion Date 2019-12-31
Primary Completion Date 2019-12-31
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Marker of blood-brain dysfunction using MRI 1 day
Markers of blood-brain dysfunction using CSF 1 day
Enrollment 132
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Contrast agent enhanced MRI using Gadovist

Description: 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.

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

The eligibility criteria are defined by the study protocol from the observational study DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).

Gender:

All

Minimum Age:

60 Years

Maximum Age:

N/A

Location
Facility: Status: Contact: Contact Backup: Charité Universitätsmedizin Berlin Oliver Peter, Prod. Dr. med. +49 30 450 517 628 [email protected]
Location Countries

Germany

Verification Date

2019-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Charite University, Berlin, Germany

Investigator Full Name: Oliver Peters

Investigator Title: Prof. dr. med. (Consultant Psychiatrist)

Has Expanded Access No
Condition Browse
Arm Group

Label: Healthy controls

Description: Healthy controls recruited through public advertisement.

Label: Siblings of people with Alzheimer's dementia

Description: Siblings of people with Alzheimer's dementia recruited through public advertisement.

Label: Subjective cognitive decline

Description: Individuals who subjectively experience cognitive decline but do not show deficits in age-, sex- and education-normed neuropsychological test results. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.

Label: Mild cognitive impairment

Description: 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.

Label: Dementia due to Alzheimer's disease

Description: 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.

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Cross-Sectional

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News