Antibiotics Against Amyloid Angiopathy | NCT05680389

Studies
Antibiotics Against Amyloid Angiopathy

NCT05680389

Sponsor

Leiden University Medical Center

Status

Unknown status

Last Update Posted

Jan 11, 2023Actual

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Cerebral Amyloid Angiopathy

Interventions

Minocycline
Placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-004786-41	EudraCT Number

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2020Actual

Primary Completion Date

Dec 2, 2023Estimated

Completion Date

Dec 2, 2023Estimated

First Submitted Date

Dec 26, 2022

First Submission Date that Met QC Criteria

Dec 26, 2022

First Posted Date

Jan 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 26, 2022

Last Update Posted Date

Jan 11, 2023Actual

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Minocycline	Experimental	100 mg twice daily for 3 months	Drug: Minocycline
Placebo	Placebo Comparator	twice daily for 3 months	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Minocycline	Drug	100 mg twice daily for 3 months	Minocycline
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
inflammatory, vessel integrity and gelatinase pathway associated biomarkers in CSF	IL6, MCP-1, IBA-1, MMP2/9, and VEGF	3 months

Secondary Outcomes

Measure	Description	Time Frame
safety and tolerability of minocycline	side effects and adverse events	3 months
progression of hemorrhagic markers on 7T MRI before and after treatment	cSS, cortical microbleeds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Sabine Voigt, BSc	Contact	+31715261825		BATMAN@lumc.nl
Marieke Wermer, PhD	Contact			BATMAN@lumc.nl

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center	Recruiting	Leiden		2333ZA	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37277877	Derived	Voigt S, Koemans EA, Rasing I, van Etten ES, Terwindt GM, Baas F, Kaushik K, van Es ACGM, van Buchem MA, van Osch MJP, van Walderveen MAA, Klijn CJM, Verbeek MM, van der Weerd L, Wermer MJH. Minocycline for sporadic and hereditary cerebral amyloid angiopathy (BATMAN): study protocol for a placebo-controlled randomized double-blind trial. Trials. 2023 Jun 5;24(1):378. doi: 10.1186/s13063-023-07371-4.

ID	Term
D002539	Cerebral Arterial Diseases
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic