NCT05605366Not yet recruitingPhase 1
Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Oct 2022
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Cincinnati
- Diseases
- Sickle cell disease
- NCT number
- NCT05605366
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 1 Dec 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- monthly therapy with chronic blood transfusions,
Other illness
- individuals with a history of overt stroke or other known neurological disorder,
- coexisting autoimmune condition due to an elevated risk for autoimmune-related complications with tetracyclines,
- tetracycline allergy.
Other
- adults with other SCD genotypes (HbSC or HbS- β+thalassemia),
- premature birth before 30 weeks gestation,
- Women who are pregnant or breast-feeding
Who the study is looking for
- Adults (age ≥ 18 years old) with SCD (HbSS and HbS-β0thalassemia genotypes only) who are followed at the University of Cincinnati Medical Center's SCD clinic are eligible to participate. As hydroxyurea is the standard-of-care in SCD, individuals on hydroxyurea will be included
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.