Minocycline for Cognitive Decline in Sickle Cell Disease
(MINO-SCD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether minocycline, typically an antibiotic, can slow or reverse cognitive decline in people with sickle cell disease (SCD). SCD may cause brain changes affecting memory, learning, and attention, possibly due to inflammation. The study examines two doses of minocycline compared to a placebo to assess safety and effectiveness in addressing cognitive issues. Adults with specific types of SCD, who are patients at the University of Cincinnati Medical Center and have no history of strokes or other neurological disorders, may qualify for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on hydroxyurea, you can continue taking it as it is the standard-of-care for sickle cell disease.
Is there any evidence suggesting that minocycline is likely to be safe for humans?
Research has shown that minocycline, the treatment under study, is generally safe for people. This antibiotic has been used to reduce inflammation in other conditions. Although it hasn't been specifically tested for sickle cell disease, it has shown potential in reducing inflammation and improving brain function in other illnesses.
Minocycline can sometimes cause side effects like changes in appetite or weight. Awareness of possible effects on teeth and bones is important, especially with long-term use. However, the doses tested in this trial (200 mg and 300 mg daily) are below the highest safe levels known from other uses, suggesting these doses should be safe with proper monitoring for any issues.12345Why are researchers excited about this trial's treatment?
Minocycline is unique because, unlike traditional treatments for cognitive decline in sickle cell disease, it is an antibiotic with anti-inflammatory properties that may help protect the brain. Standard treatments often focus on managing pain and preventing complications like infections or stroke, rather than directly addressing cognitive issues. Researchers are excited about minocycline because it targets neuroinflammation, which is thought to contribute to cognitive decline, offering a new approach that could potentially improve cognitive function in patients with sickle cell disease.
What evidence suggests that minocycline might be an effective treatment for cognitive decline in sickle cell disease?
Research shows that minocycline might help reduce brain inflammation, which is believed to cause thinking and memory problems in people with sickle cell disease (SCD). Studies in mice with conditions similar to SCD have found that minocycline greatly lowers signs of brain inflammation. This reduction is important because it can lead to better learning, memory, and focus. Minocycline has already shown promise in improving thinking and memory in other conditions, suggesting it might also help those with SCD. In this trial, participants will receive either 200 mg or 300 mg of minocycline daily, or a placebo. This treatment could offer hope for people experiencing cognitive issues due to sickle cell disease.678910
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Sickle Cell Disease (SCD), specifically HbSS and HbS-β0thalassemia genotypes, who are treated at the University of Cincinnati Medical Center's SCD clinic. It includes those on hydroxyurea treatment but excludes other SCD genotypes, history of stroke or neurological disorders, premature birth before 30 weeks, chronic blood transfusion therapy, tetracycline allergy, pregnant or breastfeeding women, and individuals with autoimmune conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 200 mg or 300 mg of minocycline daily or placebo for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Minocycline
Minocycline is already approved in United States, European Union, Japan, India for the following indications:
- Acne
- Bacterial infections
- Periodontal disease
- Rosacea
- Acne
- Bacterial infections
- Bacterial infections
- Acne
- Rosacea
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Cincinnati
Lead Sponsor