RECRUITING

Terazosin and Parkinson's Disease Extension Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate the long-term effects of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on serial in a population of subjects with defined pre-motor Parkinson's disease (PD) risks and abnormal imaging exams. Imaging changes will be correlated to the presence and severity of motor and non-motor symptoms of PD, measured by validated clinical scales and cardiac autonomic function tests.

Official Title

The Effect of Alpha1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: a Follow Up Study

Quick Facts

Study Start:2022-09-23
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05109364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrolled in the study "The Effect of alpha1- adrenergic receptor antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (STUDY #000540)
  2. * Capacity to give informed consent
  1. * Secondary Parkinsonism, including tardive
  2. * Concurrent dementia defined by a score lower than 22 on The Montreal Cognitive Assessment (MoCA)
  3. * Concurrent severe depression defined by a Beck Depression Inventory-Fast Screen (BDI fast screen) score greater than 13
  4. * Comorbidities related to sympathetic nervous system (SNS) hyperactivity
  5. * Heart failure (LVEF \<45%)
  6. * Recent myocardial revascularization (\<12 weeks)
  7. * Hypertension (systolic blood pressure SBP\>150mmHg (millimeters of mercury) or diastolic blood pressure DBP\>100mmHg)
  8. * Chronic Atrial fibrillation
  9. * Concurrent Use of Beta-adrenergic antagonist
  10. * Diabetes mellitus
  11. * Chronic Obstructive Pulmonary Disease (COPD)
  12. * Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
  13. * Severely reduced kidney function (Glomerular Filtration Rate\<30ml/min)
  14. * Contraindications to the use of terazosin
  15. * Recent myocardial infarction (\<48 h)
  16. * Ongoing angina pectoris
  17. * Cardiogenic shock or prolonged hypotension
  18. * Breast-feeding
  19. * Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
  20. * History of priapism (persistent and painful erection)
  21. * Neurogenic orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing.
  22. * Blood pressure less than 110 mm Hg systolic at screening or baseline visit
  23. * Use of investigational drugs within 30 days before screening
  24. * For female participant, pregnancy, or plans for child-bearing during study period
  25. * Allergy/hypersensitivity to iodine or study medication

Contacts and Locations

Study Contact

Michele Gregorio, PhD
CONTACT
424-315-0021
michele.gregorio@cshs.org
MaryClare Kelly, MS
CONTACT
3104238497
maryclare.kelly@cshs.org

Principal Investigator

Michele Tagliati, MD, FAAN
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Michele Tagliati, MD, FAAN, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-23
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2022-09-23
Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

  • Parkinson's disease
  • REM sleep behavior disorder (RBD)
  • Autonomic dysfunction
  • Neurodegeneration
  • Terazosin

Additional Relevant MeSH Terms

  • Symptomatic Parkinson Disease
  • REM Sleep Behavior Disorder
  • Pre-motor Parkinson's Disease