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

NCT ID: NCT04093882

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-12

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Brain Barrier Alzheimer Disease Cognitive Dysfunction Dementia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cognitive normal

Individuals who do not show clinical or neuropsychological deficits.

Contrast agent enhanced MRI using Gadovist

Intervention Type DIAGNOSTIC_TEST

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.

Contrast agent enhanced MRI using Gadovist

Intervention Type DIAGNOSTIC_TEST

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.

Contrast agent enhanced MRI using Gadovist

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Oliver Peters, MD

Prof. dr. med. (Consultant Psychiatrist)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BHSkog

Identifier Type: -

Identifier Source: org_study_id