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Prevention study for Cerebral Amyloid Angiopathy
Official title Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage
ClinicalTrials.gov ID: NCT07026994
What this study is testing
What is Colchicine 0.5mg?
Colchicine 0.5mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cerebral amyloid angiopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess the safety and tolerability of colchicine for preventing intracerebral haemorrhage (ICH) recurrence in patients with cerebral amyloid angiopathy (CAA)-ICH at high risk of recurrence. The main questions it aims to answer are: Is colchicine safe for CAA-ICH patients?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Age ≥55 years;
- Diagnosed with "probable CAA with supporting pathology" or "probable CAA" according to the modified Boston criteria (version 1.5);
- High risk of recurrent ICH, defined as: 1 prior symptomatic ICH and presence of cortical superficial siderosis (cSS), or ≥2 prior symptomatic ICHs;
- Time interval since symptom onset of the most recent ICH: ≤3 months (earlier enrollment is preferred if criteria are met);
- Modified Rankin Scale (mRS) score ≤4 at randomization;
You likely can't join if
- Secondary causes of ICH;
- Pre-existing moderate-to-severe renal, liver or blood disorders (anaemia [hemoglobin \<10g/dL], thrombocytopaenia [platelet count \<100×109/L]...
- Prior diagnosis of gout, peripheral neuropathy, myopathy, inflammatory bowel disease or chronic diarrhea;
- Concurrent treatment with regular immune-suppressant (corticosteroids, cyclophosphamide, azathioprine, mycophenolate mofetil, rituximab)...
- Known allergy, sensitivity or intolerance to colchicine;
- Contraindications or inability to complete brain MRI or susceptibility weighted imaging (SWI) scans;
See the full eligibility criteria
- Age ≥55 years;
- Diagnosed with "probable CAA with supporting pathology" or "probable CAA" according to the modified Boston criteria (version 1.5);
- High risk of recurrent ICH, defined as: 1 prior symptomatic ICH and presence of cortical superficial siderosis (cSS), or ≥2 prior symptomatic ICHs;
- Time interval since symptom onset of the most recent ICH: ≤3 months (earlier enrollment is preferred if criteria are met);
- Modified Rankin Scale (mRS) score ≤4 at randomization;
- Written informed consent from the participant or their legally authorized representative before study enrollment.
- Secondary causes of ICH;
- Pre-existing moderate-to-severe renal, liver or blood disorders (anaemia [hemoglobin \<10g/dL], thrombocytopaenia [platelet count \<100×109/L], leucopenia [white blood cell \<3×109/L], cirrhosis or severe hepatic...
- Prior diagnosis of gout, peripheral neuropathy, myopathy, inflammatory bowel disease or chronic diarrhea;
- Concurrent treatment with regular immune-suppressant (corticosteroids, cyclophosphamide, azathioprine, mycophenolate mofetil, rituximab), moderate-to-strong CYP3A4 inhibitors (atazanavir, clarithromycin...
- Known allergy, sensitivity or intolerance to colchicine;
- Contraindications or inability to complete brain MRI or susceptibility weighted imaging (SWI) scans;
- Pregnancy or breastfeeding;
- Recent participation in any other treatment study in the past 30 days before enrollment;
- Not expected to survive the follow-up period;
- Inability to adhere to study procedures;
- Any condition in which investigators believe that participating in this study may be harmful to the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Chengdu, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Chengdu, China; Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.