Blood Brain BarrierNCT04093882
The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
An observational study of Blood Brain Barrier and Alzheimer Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Brain Barrier, Alzheimer Disease, Cognitive Dysfunction
- What is being tested?
- Contrast agent enhanced MRI using Gadovist
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- 12 Sep 2019to 30 Sep 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A description of the study population is provided by DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).
Who may be able to join
- ≥ 50 years with neuropsychologically confirmed no cognitive dysfunction, mild cognitive impairment or mild dementia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Contrast agent enhanced MRI using Gadovist
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast agent enhanced MRI using GadovistDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive normal | Individuals who do not show clinical or neuropsychological deficits. Receives: 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. Receives: 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. Receives: Diagnostic Test: Contrast agent enhanced MRI using Gadovist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marker of blood-brain dysfunction using MRI
Dynamic T1 contrast enhanced sequence using Gadovist
Measured: 1 day
Markers of blood-brain dysfunction using CSF
Platelet-derived growth factor receptor-β in CSF
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start12 Sep 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Brain BarrierStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. med. Jochen Fiebach (Senior Physician)
- Responsible party
- Principal investigator, Oliver Peters, MD, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093882
- Sponsor's protocol ID
- BHSkog
- Status last verified
- Nov 2021
- First submitted
- 13 Sep 2019
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04093882
- Acronym / sponsor ID
- BHSkog
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Prof. Dr. med. Jochen Fiebach (Senior Physician)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive normal | – | Diagnostic Test: Contrast agent enhanced MRI using GadovistIndividuals who do not show clinical or neuropsychological deficits. |
| Mild cognitive impairment | – | Diagnostic Test: Contrast agent enhanced MRI using GadovistIndividuals 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. |
| Dementia due to Alzheimer's disease | – | Diagnostic Test: Contrast agent enhanced MRI using GadovistIndividuals 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A description of the study population is provided by DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).
Key inclusion criteria (1 listed)
- ≥ 50 years with neuropsychologically confirmed no cognitive dysfunction, mild cognitive impairment or mild dementia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast agent enhanced MRI using GadovistBy 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. | Diagnostic test | Cognitive normal, Dementia due to Alzheimer's disease, Mild cognitive impairment |
Primary outcome
Marker of blood-brain dysfunction using MRI
Time frame: 1 day
Dynamic T1 contrast enhanced sequence using Gadovist
Markers of blood-brain dysfunction using CSF
Time frame: 1 day
Platelet-derived growth factor receptor-β in CSF
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Brain Barrier and Alzheimer Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marker of blood-brain dysfunction using MRI (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.