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Tetracycline Antibiotic

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

Phase 1
Waitlist Available
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (1 year)

Summary

This trial will investigate if the antibiotic minocycline can stop/reverse cognitive decline in people with Sickle Cell Disease, a disorder which affects people of African ancestry and can lead to learning, memory, and attention problems due to brain inflammation.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from minocycline may include dizziness, fatigue, gastrointestinal issues like nausea or diarrhea; skin reactions such as rash; discoloration of teeth/gums; liver toxicity; and possibly an increased risk of autoimmune problems due to its anti-inflammatory properties.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of prolonged minocycline exposure in adult patients with SCD
Secondary study objectives
Cognitive Stability

Side effects data

From 2016 Phase 4 trial • 10 Patients • NCT02124811
40%
Inpatient psychiatric hospitalization
20%
Hospitalization due to ischemic colitis
20%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low CRP
High CRP

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minocycline
2019
Completed Phase 4
~1200

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
439 Previous Clinical Trials
638,718 Total Patients Enrolled

Media Library

Minocycline (Tetracycline Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05605366 — Phase 1
Sickle Cell Disease Research Study Groups: Treatment arm (1), Placebo, Treatment arm (2)
Sickle Cell Disease Clinical Trial 2023: Minocycline Highlights & Side Effects. Trial Name: NCT05605366 — Phase 1
Minocycline (Tetracycline Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05605366 — Phase 1
~20 spots leftby May 2026
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