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

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

Study Locations

      • Leiden, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center
        • Contact:

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.

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

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.

Clinical Trials on Cerebral Amyloid Angiopathy

Clinical Trials on Minocycline

3
Subscribe