Antibiotics Against Amyloid Angiopathy (NCT05680389) | Clinical Trial Compass
UnknownPhase 1/2
Antibiotics Against Amyloid Angiopathy
Netherlands60 participantsStarted 2020-12-02
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF