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-ฮฒ0thalassemia 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
Trial Overview
The study tests minocycline's safety and effectiveness in reducing brain inflammation and cognitive decline in people with SCD. Participants will be randomly assigned to receive either minocycline at two different doses (200 mg or 300 mg daily) or a placebo for one year. Their cognitive function will be assessed using the NIH Toolbox Cognition Battery at the start and end of the study.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
This arm will receive 200mg of minocycline in a single capsule per day.
This arm will receive 300 mg of minocycline in a single capsule per day. This capsule is identical in size and appearance as the 200 mg capsule
This arm will receive the placebo which is similar in size and appearance as the 200 mg and 300 mg capsules.
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
Citations
Minocycline in Neurocognitive Outcomes - Sickle Cell ...
The main reasons for this research study are to see 1) how safe and 2) how well minocycline works to try to stop/reverse cognitive decline in people with SCD.
Role of age and neuroinflammation in the mechanism of ...
Consistent with previous results, the treatment of sickle cell mice with minocycline resulted in a significant reduction in evidence of neuroinflammation. Thus, ...
3.
journals.sagepub.com
journals.sagepub.com/doi/10.1177/15353702231187646?int.sj-full-text.similar-articles.8Molecular and environmental contributors to neurological ...
Cognitive decline in individuals with sickle cell disease (SCD) is complex with diverse biological and environmental contributors. The ...
Minocycline as a potential therapy for neuroinflammation ...
Minocycline as a potential therapy for neuroinflammation and cognitive deficit in sickle cell disease ... consequences of cognitive deficit in SCD patients.
5.
researchgate.net
researchgate.net/publication/344366847_Role_of_age_and_neuroinflammation_in_the_mechanism_of_cognitive_deficits_in_sickle_cell_diseaseRole of age and neuroinflammation in the mechanism ...
A recent report demonstrated cognitive deficit in a sickle cell disease mouse model. 19 Patients with chronic pulmonary disease are at higher risk of ...
Material Safety Data Sheet
This compound was tolerated in dogs in repeat- dose toxicity studies for 5 months at low dosage; high doses caused blood effects, anorexia, body weight loss, ...
7.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9SUNPH_XIMINO_ER_CAP_90MG_30_BT.pdfMinocycline (hydrochloride) SAFETY DATA SHEET
P264: Wash {hands} thoroughly after handling. P280: Wear {protective gloves/protective clothing/eye protection/face protection}.
Minocycline: Uses, Interactions, Mechanism of Action
Intravenous minocycline should not exceed 400mg in 24 hours. Patients should be counselled regarding the risks related to tooth and bone development, ...
Safety Data Sheet
Incompatible materials: strong acids; strong bases; strong oxidizing agents; strong reducing agents. (Contd. on page 6). US. Page 6. Page 6/8.
SAFETY DATA SHEET
Skin Corrosion/Irritation. Category 2. Serious Eye Damage/Eye Irritation. Category 2. Specific target organ toxicity (single exposure). Category ...
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