Effect of Terazosin on Heart Changes in Early Parkinson's Disease
The Effect of A1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease
This study is testing if the medication terazosin can help improve heart changes in people with early signs of Parkinson's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04386317 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of terazosin, a medication typically used for benign prostatic hyperplasia and hypertension, on cardiac changes in individuals with idiopathic REM sleep behavior disorder (iRBD) who are at risk of developing Parkinson's disease. Participants will undergo specialized imaging techniques to assess myocardial uptake and correlate these findings with motor and non-motor symptoms of Parkinson's disease. The goal is to determine if terazosin can reverse early cardiac abnormalities, potentially slowing the neurodegenerative process associated with Parkinson's disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 85 with a diagnosis of idiopathic REM sleep behavior disorder and additional symptoms indicating a risk for Parkinson's disease.
Not a fit: Patients without idiopathic REM sleep behavior disorder or those who do not exhibit early symptoms of Parkinson's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help slow the progression of Parkinson's disease in at-risk individuals.
How similar studies have performed: While the use of terazosin in this context is novel, other studies have explored early interventions in Parkinson's disease with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Los Angeles, California
- Michele L Lima Gregorio — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Michele L Tagliati, MD — Cedars-Sinai Medical Center
- Study coordinator: Michele L Gregorio, PhD
- Email: michele.gregorio@cshs.org
- Phone: 4243150016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.