Minocycline for Cognitive Decline in Sickle Cell Disease (MINO-SCD Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Cincinnati

Approved in 7 jurisdictions

Trial Summary

What is the purpose of this trial?Sickle cell disease (SCD) is a common, inherited blood disorder that primarily affects people of African Ancestry. It has a lot of complications including neurological complications. The neurological complications of SCD are particularly devastating and lead to cognitive decline even in the absence of overt brain injury. In such cases, it is thought that inflammation in the brain maybe partly responsible for the cognitive decline. 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. People with SCD are at risk for changes in their brain over time that can cause problems with learning, memory, and attention. Part of the reason for this is inflammation within the brain. Minocycline may be able to stop these brain changes by stopping this brain inflammation. Minocycline is a second-generation tetracycline antibiotic that has been shown to both inhibit neuroinflammation and improve cognitive function in a variety of neurodegenerative and psychiatric disorders but has not yet been studied in SCD. We are proposing here, a pilot double-blinded, randomized controlled trial to examine the tolerability and early efficacy of minocycline in adults with SCD at two dosing regimens (200 mg and 300 mg daily) versus placebo over one year. Participants will undergo a neuropsychological exam using the NIH Toolbox Cognition Battery at both study enrollment and exit (after one year) to assess for changes/stability of cognition. Participants will receive monthly phone calls/text messages to assess for adverse events and will be seen every three months for pill counts and routine laboratory monitoring. The primary outcome will be a comparison of adverse events across the two dosing strategies versus placebo. Early evidence for cognitive benefit will also be assessed from the results of the NIH Toolbox.

Eligibility Criteria

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.

Treatment Details

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.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Treatment arm (1)Experimental Treatment1 Intervention

This arm will receive 200mg of minocycline in a single capsule per day.

Group II: Treatment arm (2)Active Control1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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, United States, United States for the following indications:

🇺🇸 Approved in United States as Minocin for: