RECRUITING

Terazosin Effect on Cardiac Changes in Early Parkinson's Disease

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Conditions

REM Sleep Behavior DisorderPre-motor Parkinson's DiseaseSymptomatic Parkinson Disease

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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

Parkinson's disease (PD) is characterized by many non-motor symptoms that occur several years before the diagnosis, in particular idiopathic REM behavior disorder (iRBD), which is associated with autonomic impairment. The purpose of this study is to investigate the effect of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on 123I-MIBG myocardial uptake in a population of subjects with defined pre-motor PD risks (i.e. hyposmia and RBD) and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms. Scintigraphic changes will be correlated to motor and non-motor severity of PD, measured by validated clinical scales and cardiac autonomic function tests.

Official Title

The Effect of A1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease

Quick Facts

Study Start:2020-11-01
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04386317

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. * Male or female of age between 50 and 85 years at time of enrollment.
  2. * Diagnosis of idiopathic REM sleep behavior disorder (iRBD), established either as 'definite RBD' according to the criteria proposed by the International Classification of Sleep Disorders (ICSD)-2 \[AASM, 2005\] or 'probable RBD' following a score of 6 or higher in the RBD questionnaire (RBDSQ) \[Nomura et al, 2011\], with a score of at least 1 in subitems 6.1 to 6.4 of question 6 \[Halsband et al, 2018\].
  3. * At least one of the following:
  4. 1. Diagnosis of hyposmia, established as a University of Pennsylvania Smell Identification Test (UPSIT) score \< 20th percentile for the individual's age group and sex.
  5. 2. Functional constipation assessed by a scores \> 4 on a questionnaire based on modified ROME IV diagnostic criteria.
  6. 3. Color vision abnormality, as assessed using HRR Pseudoisochromatic Plates, in the absence of congenital dyschromatopsia
  7. 4. Symptoms of depression, as assessed by a Beck Depression Inventory (BDI) fast screen score \>3 or concurrent use of antidepressant medications.
  8. * Abnormal 123I-MIBG myocardial scintigraphy, as defined by a Late H/M ratio \< 2.2 and/or a WR \>20%, with normal cardiac ejection fraction (LVEF \>55%).
  9. * Capacity to give informed consent
  1. * Secondary Parkinsonism, including tardive
  2. * Concurrent dementia defined by a score lower than 22 on the MOCA
  3. * Concurrent severe depression defined by a BDI fast screen score greater than 13
  4. * Comorbidites related to SNS hyperactivity
  5. * Heart failure (LVEF\< 45%)
  6. * Recent myocardial revascularization (\< 12 weeks)
  7. * Hypertension (SBP \>150 mmHg or DBP\> 100mmHg)
  8. * Chronic Atrial fibrillation
  9. * Concurrent use of Alpha- adrenergic antagonist
  10. * Diabetes mellitus
  11. * COPD
  12. * Untreated Severe Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
  13. * Contraindication to the use of Terazosin
  14. * Recent myocardial infarction (\< 48 h)
  15. * Ongoing angina pectoris
  16. * Cardiogenic shock or prolonged
  17. * Breast feeding
  18. * Current use of Phosphodiesterase type 5 inhibitors: sildenafil (Viagra TM), tadalafil (Cialis TM), or vardenafil (Levitra TM)
  19. * History of Priapism
  20. * Neurogenic orthostatic hypotensiondefiened as symptomatic decrease in BP\> 20 mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing
  21. * Blood pressure less than 110 mmHG systolic at screening or baseline visit
  22. * Use of investigational drugs whitin 30 days before screening
  23. * For female participant, Pregnacy, or plans for child-bearing during study period
  24. * Allergy/hypersenstivity to iodine or study medication

Contacts and Locations

Study Contact

Michele L Gregorio, PhD
CONTACT
4243150016
michele.gregorio@cshs.org
MaryClare Kelly
CONTACT
3104238497
maryclare.kelly@cshs.org

Principal Investigator

Michele L Tagliati, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Michele L Lima Gregorio
Los Angeles, California, 90046
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Michele L Tagliati, MD, 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 Date2020-11-01
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2020-11-01
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

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