- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680389
Antibiotics Against Amyloid Angiopathy (BATMAN)
December 26, 2022 updated by: Marieke JH Wermer, MD, Leiden University Medical Center
Placebo-controlled, Randomized, Double-blind Study of Minocycline for Sporadic and Hereditary Cerebral Amyloid Angiopathy
We will perform a randomized clinical trial with minocycline.
Minocycline is an antibiotic of the tetracycline family and known to modulate inflammation, gelatinase activity and angiogenesis, which we know are central mechanisms in CAA-pathology.
Our aim is to prove in a randomized clinical trial in a translational setting that minocycline treatment (duration 3 months) can decrease markers of neuroinflammation and the gelatinase pathway in the cerebrospinal fluid (CSF) of persons with D-CAA (n=30) and sporadic-CAA (n=30).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabine Voigt, BSc
- Phone Number: +31715261825
- Email: BATMAN@lumc.nl
Study Contact Backup
- Name: Marieke Wermer, PhD
- Email: BATMAN@lumc.nl
Study Locations
-
-
-
Leiden, Netherlands, 2333ZA
- Recruiting
- Leiden University Medical Center
-
Contact:
- Sabine Voigt, BSc
- Phone Number: +31715261825
- Email: BATMAN@lumc.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years for D-CAA and age ≥55 years for sporadic-CAA
- Probable-CAA according to the Modified-Boston-Criteria or genetically proven D-CAA
- ≤ 2 ICH (occurrence of ICHs at least 1 year ago) and presence of ≥ 2 lobar microbleeds +/-cortical superficial siderosis
- Written informed consent
Exclusion Criteria:
- Previous allergic reactions to minocycline
- Modified Rankin Score ≥3
- Contraindications, such as:
- Contraindications for 7T MRI as determined by the 7Tesla safety committee. Examples of possible contra-indications are: claustrophobia, pacemakers and defibrillators, nerve stimulators, intracranial clips, intraorbital or intraocular metallic fragments, cochlear implants, ferromagnetic implants, hydrocephalus pump, intra-uterine device, permanent make-up, tattoos above the shoulders. In case of specific contra-indications for 7T a 3T will be made instead. - Specific contraindications for checkerboard fMRI: seizure within prior year, photosensitive epilepsy, noncorrectable visual impairment. - Contraindications for lumbar puncture: compression of the spinal cord, signs and symptoms of increased intracranial pressure, local infections of the skin at the puncture site, a coagulopathy or thrombocytopenia (<100). (Use of acetylsalicylic acid, NSAIDs, COX2 inhibitors or low-molecular-weight heparin are no contraindications for lumbar puncture.)
- Pregnancy/breast feeding
- Liver/renal failure
- Use of antibiotics <1 month
- SLE or other diseases known to generate inflammatory responses
- Previous/current/planned use of retinoids (since this is related to increasing risk of increased intracranial pressure)
- Current use of anaesthetics like methoxyflurane, agents inhibiting peristalsis, barbiturates, carbamazepine or fenytoïne
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Minocycline
100 mg twice daily for 3 months
|
100 mg twice daily for 3 months
|
Placebo Comparator: Placebo
twice daily for 3 months
|
twice daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF
Time Frame: 3 months
|
IL6, MCP-1, IBA-1, MMP2/9, and VEGF
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety and tolerability of minocycline
Time Frame: 3 months
|
side effects and adverse events
|
3 months
|
progression of hemorrhagic markers on 7T MRI before and after treatment
Time Frame: 3 months
|
cSS, cortical microbleeds
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2020
Primary Completion (Anticipated)
December 2, 2023
Study Completion (Anticipated)
December 2, 2023
Study Registration Dates
First Submitted
December 26, 2022
First Submitted That Met QC Criteria
December 26, 2022
First Posted (Estimate)
January 11, 2023
Study Record Updates
Last Update Posted (Estimate)
January 11, 2023
Last Update Submitted That Met QC Criteria
December 26, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Proteostasis Deficiencies
- Metabolism, Inborn Errors
- Brain Diseases, Metabolic
- Brain Diseases, Metabolic, Inborn
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Cerebral Small Vessel Diseases
- Amyloidosis, Familial
- Amyloidosis
- Cerebral Amyloid Angiopathy
- Cerebral Amyloid Angiopathy, Familial
- Anti-Infective Agents
- Anti-Bacterial Agents
- Minocycline
Other Study ID Numbers
- P19.110
- 2019-004786-41 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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