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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)
Awards & highlights
MINO-SCD Trial 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.Check my eligibility
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.See study design
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.
MINO-SCD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months (1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of prolonged minocycline exposure in adult patients with SCD
Secondary outcome measures
Cognitive Stability
Side effects data
From 2016 Phase 4 trial • 10 Patients • NCT0212481140%
Inpatient psychiatric hospitalization
20%
Hospitalization due to ischemic colitis
20%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low CRP
High CRP
MINO-SCD 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
2005
Completed Phase 4
~1000
Find a Location
Who is running the clinical trial?
University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,356 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke or another neurological disorder.I have sickle cell disease but not the SS genotype.I am taking hydroxyurea for sickle cell disease.I am over 18 with SCD and am a patient at the University of Cincinnati's SCD clinic.I have an autoimmune condition that could worsen with certain medications.I receive monthly blood transfusions for my condition.I am not pregnant or breast-feeding.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment arm (2)
- Group 2: Treatment arm (1)
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is Treatment arm (1) secure for participants?
"Treatment arm (1) is rated a 1 on our safety scale, as this is an early Phase I trial with limited data indicating it's efficacy and safety."
Answered by AI
Is the enrollment period for this trial still active?
"Clinicaltrials.gov indicates that the enrollment process for this clinical trail has been temporarily suspended, with its inception on December 1st 2022 and last update being October 28th 2022. Though no longer accepting participants, there are 864 other medical studies recruiting patients at present."
Answered by AI
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