Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
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.