Terazosin Effect on Cardiac Changes in Early Parkinson's Disease

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.

Conditions

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

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Study Details

Study overview

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.

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

Terazosin Effect on Cardiac Changes in Early Parkinson's Disease

Condition
REM Sleep Behavior Disorder
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female of age between 50 and 85 years at time of enrollment.
  • * 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 \[Halsband et al, 2018\].
  • * At least one of the following:
  • 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.
  • 2. Functional constipation assessed by a scores \> 4 on a questionnaire based on modified ROME IV diagnostic criteria.
  • 3. Color vision abnormality, as assessed using HRR Pseudoisochromatic Plates, in the absence of congenital dyschromatopsia
  • 4. Symptoms of depression, as assessed by a Beck Depression Inventory (BDI) fast screen score \>3 or concurrent use of antidepressant medications.
  • * 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%).
  • * Capacity to give informed consent
  • * Secondary Parkinsonism, including tardive
  • * Concurrent dementia defined by a score lower than 22 on the MOCA
  • * Concurrent severe depression defined by a BDI fast screen score greater than 13
  • * Comorbidites related to SNS hyperactivity
  • * Heart failure (LVEF\< 45%)
  • * Recent myocardial revascularization (\< 12 weeks)
  • * Hypertension (SBP \>150 mmHg or DBP\> 100mmHg)
  • * Chronic Atrial fibrillation
  • * Concurrent use of Alpha- adrenergic antagonist
  • * Diabetes mellitus
  • * COPD
  • * Untreated Severe Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
  • * Contraindication to the use of Terazosin
  • * Recent myocardial infarction (\< 48 h)
  • * Ongoing angina pectoris
  • * Cardiogenic shock or prolonged
  • * Breast feeding
  • * Current use of Phosphodiesterase type 5 inhibitors: sildenafil (Viagra TM), tadalafil (Cialis TM), or vardenafil (Levitra TM)
  • * History of Priapism
  • * Neurogenic orthostatic hypotensiondefiened as symptomatic decrease in BP\> 20 mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing
  • * Blood pressure less than 110 mmHG systolic at screening or baseline visit
  • * Use of investigational drugs whitin 30 days before screening
  • * For female participant, Pregnacy, or plans for child-bearing during study period
  • * Allergy/hypersenstivity to iodine or study medication

Ages Eligible for Study

50 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cedars-Sinai Medical Center,

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

Study Record Dates

2025-12-30