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

Completed

• Conditions: Alzheimer Disease; Blood Brain Barrier; Dementia; Cognitive Dysfunction
• Interventions: Diagnostic Test: Contrast agent enhanced MRI using Gadovist

• Registration Number: NCT04093882
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-12
• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-18
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild cognitive impairment	Contrast agent enhanced MRI using Gadovist	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.
Cognitive normal	Contrast agent enhanced MRI using Gadovist	Individuals who do not show clinical or neuropsychological deficits.
Dementia due to Alzheimer's disease	Contrast agent enhanced MRI using Gadovist	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.

Primary Outcome Measures

Name	Time	Method
Marker of blood-brain dysfunction using MRI	1 day	Dynamic T1 contrast enhanced sequence using Gadovist
Markers of blood-brain dysfunction using CSF	1 day	Platelet-derived growth factor receptor-β in CSF

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany