Cerebral Amyloid AngiopathyPhase 1/2BATMANNCT05680389
Antibiotics Against Amyloid Angiopathy
A Phase 1/2 study testing Minocycline in people with Cerebral Amyloid Angiopathy, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Amyloid Angiopathy
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Dec 2020to 2 Dec 2023
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Marieke Wermer, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Sabine Voigt, BSc, +31715261825, BATMAN@lumc.nl
About this study
Official title: 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).
- Conditions
- Cerebral Amyloid Angiopathy
- Being tested
- Minocycline, Placebo
- Medical subject headings
- Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
100 mg twice daily for 3 months
PlaceboDrug
twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | 100 mg twice daily for 3 months Receives: Drug: Minocycline |
| Placebo | Placebo comparator | twice daily for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF
IL6, MCP-1, IBA-1, MMP2/9, and VEGF
Measured: 3 months
Secondary outcomes (2)
safety and tolerability of minocycline
side effects and adverse events
Measured: 3 months
progression of hemorrhagic markers on 7T MRI before and after treatment
cSS, cortical microbleeds
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start2 Dec 2020
- Primary completion2 Dec 2023 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Amyloid AngiopathyStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marieke JH Wermer, MD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680389
- Sponsor's protocol ID
- P19.110
- Other IDs
- 2019-004786-41, 2019
- Acronym
- BATMAN
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Voigt S, Koemans EA, Rasing I, van Etten ES, Terwindt GM, Baas F, Kaushik K, van Es ACGM, van Buchem MA, van Osch MJP, van Walderveen MAA, Klijn CJM, Verbeek MM, van der Weerd L, Wermer MJH. Minocycline for sporadic and hereditary cerebral amyloid angiopathy (BATMAN): study protocol for a placebo-controlled randomized double-blind trial. Trials. 2023 Jun 5;24(1):378. doi: 10.1186/s13063-023-07371-4.
PubMed 37277877
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled, Randomized, Double-blind Study of Minocycline for Sporadic and Hereditary Cerebral Amyloid Angiopathy
- ClinicalTrials.gov ID
- NCT05680389
- Acronym / sponsor ID
- BATMAN / P19.110
- Conditions
- Cerebral Amyloid Angiopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 2 Dec 2023 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 11 Jan 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline100 mg twice daily for 3 months |
| Placebo | Placebo comparator | Drug: Placebotwice daily for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Minocycline100 mg twice daily for 3 months | Drug | Minocycline |
| Placebotwice daily for 3 months | Drug | Placebo |
Primary outcome
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF
Time frame: 3 months
IL6, MCP-1, IBA-1, MMP2/9, and VEGF
2 secondary outcomes
safety and tolerability of minocycline
Time frame: 3 months
progression of hemorrhagic markers on 7T MRI before and after treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 37277877Voigt S, Koemans EA, Rasing I, van Etten ES, Terwindt GM, Baas F, Kaushik K, van Es ACGM, van Buchem MA, van Osch MJP, van Walderveen MAA, Klijn CJM, Verbeek MM, van der Weerd L, Wermer MJH. Minocycline for sporadic and hereditary cerebral amyloid angiopathy (BATMAN): study protocol for a placebo-controlled randomized double-blind trial. Trials. 2023 Jun 5;24(1):378. doi: 10.1186/s13063-023-07371-4.
- 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.
Marieke Wermer, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Minocycline in people with Cerebral Amyloid Angiopathy, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Voigt, BSc (+31715261825, BATMAN@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680389, which also lists 1 linked publication.
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 Jan 2023.