Mino-Scd: Minocycline In Neurocognitive Outcomes – Sickle Cell Disease
Posted Date: Jun 7, 2022
- Investigator: Kristine Karkoska
- Type of Study: Drug
Individuals with sickle cell disease (SCD) are at risk for progressive cognitive delay beginning in infancy. Although the neurovascular complications of SCD-related cognitive decline are well-described, neuroinflammation due to activated microglia is increasingly recognized as a contributing factor to this progressive decline. The tetracycline antibiotic minocycline crosses the blood brain barrier and inhibits neuroinflammation; studies from other neurodegenerative disorders in humans and SCD mice show some efficacy in improving cognitive deficits. This is will be a pilot phase I trial to determine safety and early efficacy of the ability of minocycline to slow the rate of cognitive decline in individuals with SCD over one year. Participants will be randomly assigned to receive either 200 mg daily, 300 mg daily, or placebo for 12 months; both participants and study personnel will be blinded. Participants will undergo a brief neuropsychological evaluation at baseline and at study exit; they will have monthly pill box refills (which may be completed virtually or in person), every three month in person lab and exam visits, and weekly electronic surveys about side effects/compliance with medication. Individuals who are pregnant or wish to become pregnant will be excluded. All study-related visits will take place in the Schubert Research Clinic at Cincinnati Children's Hospital Medical Center. Participants will be paid up to $305 for their time via UC ClinCard over the course of the year.
Adults Aged At Least 18 Years Old With Sickle Cell Disease (Hbss Or Hbs-Beta 0 Thalassemia Genotypes)
Sickle Cell Disease, Cognition
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