Terazosin and Parkinson's Disease Extension Study

NCT ID: NCT05109364

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2025-11-01

Brief Summary

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.

Detailed 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 123 Ioflupane Dopamine Transporter single-photon emission-computed tomography (123I-FP DAT-SPECT) in a population of subjects with defined pre-motor PD risks (i.e., RBD and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal Iodine-123 meta-iodobenzylguanidine (123I-MIBG) uptake. 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. The rate of RBD clinical conversion to PD will be estimated and compared to available data in the literature.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

terazosin therapy extension

Primary procedures in this study are MIBG scan, DAT scan, NM-MRI, and terazosin medication. Subjects will return for research visits and imaging every six months for three years. The investigators hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the alpha1- adrenergic receptor antagonist terazosin, resulting in a decreased clinical conversion rate to parkinsonism.

Group Type: EXPERIMENTAL

Terazosin therapy

Intervention Type: DRUG

Primary procedures in this study are MIBG scan, DAT scan, NM-MRI, and terazosin titration. Subjects will return for research visits and imaging every six months for three years. The investigators hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the a1- Adrenergic Receptor Antagonist Terazosin, resulting in a decreased clinical conversion rate to parkinsonism.

Interventions

Terazosin therapy

Primary procedures in this study are MIBG scan, DAT scan, NM-MRI, and terazosin titration. Subjects will return for research visits and imaging every six months for three years. The investigators hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the a1- Adrenergic Receptor Antagonist Terazosin, resulting in a decreased clinical conversion rate to parkinsonism.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)
• Capacity to give informed consent

Exclusion Criteria

• Secondary Parkinsonism, including tardive
• Concurrent dementia defined by a score lower than 22 on The Montreal Cognitive Assessment (MoCA)
• Concurrent severe depression defined by a Beck Depression Inventory-Fast Screen (BDI fast screen) score greater than 13
• Comorbidities related to sympathetic nervous system (SNS) hyperactivity
• Heart failure (LVEF <45%)
• Recent myocardial revascularization (<12 weeks)
• Hypertension (systolic blood pressure SBP>150mmHg (millimeters of mercury) or diastolic blood pressure DBP>100mmHg)
• Chronic Atrial fibrillation
• Concurrent Use of Beta-adrenergic antagonist
• Diabetes mellitus
• Chronic Obstructive Pulmonary Disease (COPD)
• Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) > 30/h.
• Severely reduced kidney function (Glomerular Filtration Rate<30ml/min)
• Contraindications to the use of terazosin
• Recent myocardial infarction (<48 h)
• Ongoing angina pectoris
• Cardiogenic shock or prolonged hypotension
• Breast-feeding
• Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
• History of priapism (persistent and painful erection)
• Neurogenic orthostatic hypotension defined as symptomatic decrease in BP > 20mmHg systolic or > 10mmHg diastolic and HR increase < 20bpm on supine to sitting or standing.
• Blood pressure less than 110 mm Hg systolic at screening or baseline visit
• Use of investigational drugs within 30 days before screening
• For female participant, pregnancy, or plans for child-bearing during study period
• Allergy/hypersensitivity to iodine or study medication

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michele Tagliati, MD

Professor and Vice Chairman, Director of Movement Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Tagliati, MD, FAAN

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michele Gregorio, PhD

Role: CONTACT

michele.gregorio@cshs.org

424-315-0021 ext. 50021

MaryClare Kelly, MS

Role: CONTACT

maryclare.kelly@cshs.org

3104238497 ext. 1704

Facility Contacts

Michele L Gregorio, PhD

Role: primary

michele.gregorio@cshs.org

4243150021 ext. 50021

MaryClare Kelly, MS

Role: backup

maryclare.kelly@cshs.org

310-423-8497 ext. 38497

Michele Tagliati

Role: backup

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Other Identifiers

STUDY00001770

Identifier Type: -

Identifier Source: org_study_id