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

Phase 2
Recruiting
Conditions
CAA
cerebral amyloid angiopathy
10007963
Registration Number
NL-OMON54550
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
60
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 ICH (occurrence of ICHs at least 1 year ago) and presence of >= 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

- 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 (<40).
(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 & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Markers of neuroinflammation and the gelatinase pathway in the CSF.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The effect of minocycline on microvascular CAA markers on 7 Tesla MRI.</p><br>
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