Minocycline In Neurocognitive Outcomes - Sickle Cell Disease

Sponsor
University of Cincinnati
Study ID
NCT05605366
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Cognitive Change
  • Cognitive Decline
  • Cognitive Deficit
  • Cognitive Dysfunction
  • Cognitive Impairment
  • Neuroinflammatory Response
  • Sickle Cell Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Minocycline — DRUG
    Minocycline is a second-generation tetracycline antibiotic with good central nervous system penetration and anti-neuroinflammatory effect.
  • Placebo — DRUG
    This is capsule that is identical in size and appearance as the drug, but without active drug ingredient.

Study Details

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.

Key Dates

First listed
Nov 4, 2022
Start date
Dec 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 15, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm (1)
    This arm will receive 200mg of minocycline in a single capsule per day.
  • Active Comparator: Treatment arm (2)
    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
  • Placebo Comparator: Placebo
    This arm will receive the placebo which is similar in size and appearance as the 200 mg and 300 mg capsules.

Primary Outcome Measure

Safety and tolerability of prolonged minocycline exposure in adult patients with SCD [ Time Frame: 12 months (1 year) ]

Central Contacts

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