← Back to all trials
Recruiting
NCT05680389
Antibiotics Against Amyloid Angiopathy
Conditions: Cerebral Amyloid Angiopathy
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1, PHASE2
Enrollment: 60
Sponsor: Leiden University Medical Center
Location: Netherlands
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.
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).
Eligibility Criteria
Inclusion Criteria:Age ≥18 years for D-CAA and age ≥55 years for sporadic-CAAProbable-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 siderosisWritten informed consentExclusion Criteria:Previous allergic reactions to minocyclineModified Rankin Score ≥3Contraindications, 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 feedingLiver/renal failureUse of antibiotics <1 monthSLE or other diseases known to generate inflammatory responsesPrevious/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
Source: ClinicalTrials.gov (NCT05680389). StuddyBuddy aggregates publicly available trial information.