Target Engagement of Terazosin in Healthy Adults

NCT ID: NCT04551040

Last Updated: 2025-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2025-06-30

Brief Summary

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The purpose of the study is to assess the target engagement of Terazosin (TZ) in a single cohort of 6 healthy adult participants. During the study participants will undergo PET/CT scans, 7-Tesla MRI scans, blood draws, and an optional lumbar puncture (LP.)

Detailed Description

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The study is a single center, 37-day, controlled pilot study to assess the target engagement of Terazosin (TZ) in a single cohort of 6 healthy adult participants (3 men and 3 women.) During the study participants will undergo PET/CT scans, 7-Tesla MRI scans, blood draws, and an optional lumbar puncture (LP.) Participants will have their baseline ATP levels measured (at 0mg TZ.) They will then take doses of TZ at 1mg and will increase their dose on a weekly basis by 1mg until they reach a total dose of 5mg. ATP levels will be assessed on study days 8 and 36. Participants interested in voluntarily donating a sample of cerebral spinal fluid will undergo an optional lumbar puncture on study day 37.

The purpose of the study is to gain a better understanding of the mechanisms in which TZ acts in the brain. TZ was recently discovered to increase energy levels (in the form of ATP molecules) in the brain by enhancing glycolysis. By using different brain imaging techniques, blood assays and cerebral spinal fluid assays, the study will attempt to: 1) quantify the rate of glycolysis in the brain at different dosages of TZ, 2) quantify ATP levels in the brain at different dosages of TZ, 3) quantify ATP levels in blood at different dosages of TZ, and 4) assess the brain permeability of TZ. It is hoped that knowledge gained from the study will help guide future clinical trials using TZ for the treatment of various neurodegenerative diseases such as Parkinson's Disease.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group of healthy older adults
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Primary Cohort

Titrating doses of terazosin starting at 1mg daily and increasing to 5mg daily on a weekly basis for five weeks.

Group Type EXPERIMENTAL

Terazosin

Intervention Type DRUG

Terazosin 1 mg oral capsule

Interventions

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Terazosin

Terazosin 1 mg oral capsule

Intervention Type DRUG

Other Intervention Names

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Hytrin

Eligibility Criteria

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Inclusion Criteria

* Healthy Men or women aged 60-90

Exclusion Criteria

* History of stroke
* Ineligibility for MRI (e.g. soft tissue metallic implants, clips, cardiac pacemaker, cardiac defibrillator, internal pacing wires, metallic fragments, shrapnel, etc.)
* Current use of more than one of the following classes of medications: beta blockers, ace inhibitors, angiotensin receptor blockers, calcium channel blockers, or diuretics
* Use of any alpha blockers (terazosin, doxazosin, alfuzosin, prazosin, or tamsulosin) in the past year.
* Current use of the over-the-counter supplement yohimbe
* Orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing.
* Alcohol and drug abuse
* Clinically significant traumatic brain injury
* History of Type I diabetes
* Uncontrolled Type II diabetes
* Other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study or increase fall risk
* Use of investigational drugs within 30 days before screening
* History of hemodynamic instability
* For females: pregnancy or breastfeeding
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Jordan Schultz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordan Schultz, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Chen X, Zhao C, Li X, Wang T, Li Y, Cao C, Ding Y, Dong M, Finci L, Wang JH, Li X, Liu L. Terazosin activates Pgk1 and Hsp90 to promote stress resistance. Nat Chem Biol. 2015 Jan;11(1):19-25. doi: 10.1038/nchembio.1657. Epub 2014 Nov 10.

Reference Type BACKGROUND
PMID: 25383758 (View on PubMed)

Cai R, Zhang Y, Simmering JE, Schultz JL, Li Y, Fernandez-Carasa I, Consiglio A, Raya A, Polgreen PM, Narayanan NS, Yuan Y, Chen Z, Su W, Han Y, Zhao C, Gao L, Ji X, Welsh MJ, Liu L. Enhancing glycolysis attenuates Parkinson's disease progression in models and clinical databases. J Clin Invest. 2019 Oct 1;129(10):4539-4549. doi: 10.1172/JCI129987.

Reference Type BACKGROUND
PMID: 31524631 (View on PubMed)

Schapira AH. Mitochondria in the aetiology and pathogenesis of Parkinson's disease. Lancet Neurol. 2008 Jan;7(1):97-109. doi: 10.1016/S1474-4422(07)70327-7.

Reference Type BACKGROUND
PMID: 18093566 (View on PubMed)

Hoyer S. Brain glucose and energy metabolism during normal aging. Aging (Milano). 1990 Sep;2(3):245-58. doi: 10.1007/BF03323925.

Reference Type BACKGROUND
PMID: 1982730 (View on PubMed)

Cunnane S, Nugent S, Roy M, Courchesne-Loyer A, Croteau E, Tremblay S, Castellano A, Pifferi F, Bocti C, Paquet N, Begdouri H, Bentourkia M, Turcotte E, Allard M, Barberger-Gateau P, Fulop T, Rapoport SI. Brain fuel metabolism, aging, and Alzheimer's disease. Nutrition. 2011 Jan;27(1):3-20. doi: 10.1016/j.nut.2010.07.021. Epub 2010 Oct 29.

Reference Type BACKGROUND
PMID: 21035308 (View on PubMed)

Blesa J, Phani S, Jackson-Lewis V, Przedborski S. Classic and new animal models of Parkinson's disease. J Biomed Biotechnol. 2012;2012:845618. doi: 10.1155/2012/845618. Epub 2012 Mar 28.

Reference Type BACKGROUND
PMID: 22536024 (View on PubMed)

Hoffe B, Holahan MR. The Use of Pigs as a Translational Model for Studying Neurodegenerative Diseases. Front Physiol. 2019 Jul 10;10:838. doi: 10.3389/fphys.2019.00838. eCollection 2019.

Reference Type BACKGROUND
PMID: 31354509 (View on PubMed)

Hoegger MJ, Fischer AJ, McMenimen JD, Ostedgaard LS, Tucker AJ, Awadalla MA, Moninger TO, Michalski AS, Hoffman EA, Zabner J, Stoltz DA, Welsh MJ. Impaired mucus detachment disrupts mucociliary transport in a piglet model of cystic fibrosis. Science. 2014 Aug 15;345(6198):818-22. doi: 10.1126/science.1255825.

Reference Type BACKGROUND
PMID: 25124441 (View on PubMed)

Rogers CS, Stoltz DA, Meyerholz DK, Ostedgaard LS, Rokhlina T, Taft PJ, Rogan MP, Pezzulo AA, Karp PH, Itani OA, Kabel AC, Wohlford-Lenane CL, Davis GJ, Hanfland RA, Smith TL, Samuel M, Wax D, Murphy CN, Rieke A, Whitworth K, Uc A, Starner TD, Brogden KA, Shilyansky J, McCray PB Jr, Zabner J, Prather RS, Welsh MJ. Disruption of the CFTR gene produces a model of cystic fibrosis in newborn pigs. Science. 2008 Sep 26;321(5897):1837-41. doi: 10.1126/science.1163600.

Reference Type BACKGROUND
PMID: 18818360 (View on PubMed)

Hytrin (terazosin) [package insert]. Abbott Indistries, North Chicago, IL. 2001.

Reference Type BACKGROUND

Matthews DC, Lerman H, Lukic A, Andrews RD, Mirelman A, Wernick MN, Giladi N, Strother SC, Evans KC, Cedarbaum JM, Even-Sapir E. FDG PET Parkinson's disease-related pattern as a biomarker for clinical trials in early stage disease. Neuroimage Clin. 2018 Aug 10;20:572-579. doi: 10.1016/j.nicl.2018.08.006. eCollection 2018.

Reference Type BACKGROUND
PMID: 30186761 (View on PubMed)

Patel A, Malinovska L, Saha S, Wang J, Alberti S, Krishnan Y, Hyman AA. ATP as a biological hydrotrope. Science. 2017 May 19;356(6339):753-756. doi: 10.1126/science.aaf6846.

Reference Type BACKGROUND
PMID: 28522535 (View on PubMed)

Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm. 2016 Mar;7(2):27-31. doi: 10.4103/0976-0105.177703.

Reference Type BACKGROUND
PMID: 27057123 (View on PubMed)

Other Identifiers

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202005461

Identifier Type: -

Identifier Source: org_study_id

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