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Effect of Terazosin on ATP Levels in People With Amyotrophic Lateral Sclerosis

Not Applicable
Not yet recruiting
Conditions
Amyotrophic Lateral Sclerosis
Terazosin
Adenosine Triphosphate Activities
Interventions
Registration Number
NCT07224269
Lead Sponsor
University of Iowa
Brief Summary

This will be a single center, open label pilot study to assess the safety and tolerability of terazosin (TZ) at a dose of 5 milligrams (mg) per os (PO) daily for patients with amyotrophic lateral sclerosis (ALS). The primary outcome of this study is to determine whether TZ increases adenosine triphosphate (ATP) levels in ALS. We will measure adverse outcomes, safety, and tolerability of taking TZ. Procedures include blood draws, spirometry, lumbar punctures, fluorodeoxyglucose-positron emission tomography (FDG-PET) scans, questionnaires, and physical examinations. TZ will be titrated up to 5 mg PO daily. This is a pilot study and is not powered to assess efficacy of this medication. Our hope is that this study will guide future studies of this (and similar) medications for the disease modification of ALS. This study also aims to learn more about how patients produce and use energy and if TZ can help to reverse energy deficits that appear in ALS.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TerazosinTerazosine-
Primary Outcome Measures
NameTimeMethod
Change in ATP levelsBaseline and 12 weeks

Mean percent change from baseline to 12 weeks in whole-blood ATP and brain glycolytic rate using FDG-PET imaging

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Iowa Health Care

🇺🇸

Iowa City, Iowa, United States

University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States
Emily Anderson, RN, MSN
Contact
319-356-8744
emily-anderson@uiowa.edu
Heena Olalde, RN, MSN
Contact
319-356-8326
heena-olalde@uiowa.edu
Andrea Swenson, MD
Principal Investigator

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