Study 3: Minocycline Decreases Microglia Activation

University of Florida

Status and phase: Completed; Phase 2

Conditions: Hypertension

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02213575

R01HL132448 (U.S. NIH Grant/Contract)

RO1HL3361028 (Other Identifier)

IRB201500594 -N

2013-00102 Study 3 (Other Identifier)

Details and patient eligibility

About

This study is a mechanistic study that will enroll 9 subjects who are participating in NCT02133872 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in PET and MRI imaging.

Full description

This study (Study 3) will recruit 9 subjects from NCT02133872 (Study1) who will agree to undergo additional autonomic testing and imaging studies at baseline and after 6 months of study treatment. Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in Montreal Canada.

For this study (Study 3) we include participants being enrolled Study 1 and/or participants who have completed participation in Study 1 and have not taken minocycline for 2 months will be approached to enroll in Study 3.

Enrollment: 5 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Minocycline Subjects:

• Subjects participating in Study 1 will be eligible to participate.
• (For Study 3 Participants only) Willing to travel to Montreal, Canada for specialized imaging of the participant's brain using magnetic resonance imaging (MRI), positron emission tomography (PET) scanning, Autonomic Nervous System Testing and blood drawing- if participant qualifies

Exclusion Criteria for Minocycline Subjects:

-Female participants with positive pregnancy test.

Inclusion Criteria for Controls:

• No diagnosis of neurogenic (treatment-resistant) hypertension.
• Not treated with minocycline.
• Willing to travel to Montreal, Canada for brain imaging and testing.
• Able to provide informed consent.

Exclusion Criteria for Controls:

-Female participants with positive pregnancy test.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Minocycline Treatment Group

Experimental group

Description:

Participants with neurogenic treatment-resistant hypertension who meet inclusion/exclusion criteria will receive minocycline at a dose determined to be most effective in lowering blood pressure (based on results from Study 1). Participants will undergo brain imaging with MRI and PET at baseline and 26 weeks. Intervention: Drug: Minocycline Dose: 50, 100, or 200 mg/day (based on optimal BP-lowering dose from Study 1) Frequency: Administered orally twice daily (BID) Duration: 26 weeks

Treatment:

Drug: Minocycline

Control

No Intervention group

Description:

Patients without a diagnosis of neurogenic (treatment-resistant) Hypertension and have not been treated with minocycline will be recruited. These participants will undergo one-time brain imaging visit (MRI and PET)