'BATMAN' antibiotics against amyloid angiopathy: a placebo-controlled, randomized, double-blind study of minocycline for sporadic and hereditary cerebral amyloid angiopathy.

'BATMAN' antibiotics against amyloid angiopathy: a placebo-controlled, randomized, double-blind study of minocycline for sporadic and hereditary cerebral amyloid angiopathy. - BATMAN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54550

Enrollment

Registered

2020-08-21

Start date

2020-12-02

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAA cerebral amyloid angiopathy

Interventions

60 patients will be randomized and receive either placebo or minocycline treatment (15 sCAA placebo, 15 sCAA minocycline, 15 D-CAA placebo and 15 D-CAA minocycline).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >=18 years for HCHWA-D and age >=50 years for sporadic-CAA - Probable-CAA according to the Boston criteria 2.0, or genetically proven D-CAA - = 2 lobar microbleeds +/-cortical superficial siderosis - Presence of deep microbleeds is allowed if - There is presence of cortical superficial siderosis, or - >=10 lobar microbleeds are present for every deep microbleed - Written informed consent

Exclusion criteria

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. - Specific contraindications for 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 including use of anti-coagulant drugs (INR>=1.8) or thrombocytopenia (

Design outcomes

Primary

Measure	Time frame
Markers of neuroinflammation and the gelatinase pathway in the CSF.	—

Secondary

Measure	Time frame
The effect of minocycline on microvascular CAA markers on 7 Tesla MRI.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)