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

NCT04093882 | Completed

• 1 other identifier: BHSkog
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Brain Barrier; Alzheimer Disease; Cognitive Dysfunction; Dementia

Outcome Measures

Primary Outcomes (2)

• Marker of blood-brain dysfunction using MRI

  Dynamic T1 contrast enhanced sequence using Gadovist

  1 day

• Markers of blood-brain dysfunction using CSF

  Platelet-derived growth factor receptor-β in CSF

  1 day

Study Arms (3)

Cognitive normal

Individuals who do not show clinical or neuropsychological deficits.

Diagnostic Test: Contrast agent enhanced MRI using Gadovist

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

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

Interventions

Contrast agent enhanced MRI using Gadovist 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.

Cognitive normal; Dementia due to Alzheimer's disease; Mild cognitive impairment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A description of the study population is provided by DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).

You may qualify if:

• \- ≥ 50 years with neuropsychologically confirmed no cognitive dysfunction, mild cognitive impairment or mild dementia
• 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

Sponsors & Collaborators

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

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebro-spinal fluid

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. med. (Consultant Psychiatrist)

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 18, 2019
• Study Start: September 12, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)