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Alpha-1 Adrenergic Blocker

Terazosin Therapy for Parkinson's Disease

Phase 2

Recruiting

Led By Michele Tagliati, MD, FAAN

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to give informed consent

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial will study the long-term effects of a1-adrenergic blocker terazosin on people with early signs of Parkinson's disease.

Who is the study for?

This trial is for people who were part of a previous Parkinson's study, can consent, and don't have conditions like secondary Parkinsonism, dementia, severe depression, recent heart issues or certain other health problems. It's not for those with low blood pressure, untreated sleep apnea, heart failure or kidney issues.Check my eligibility

What is being tested?

The study tests the long-term effects of Terazosin on people at risk for pre-motor Parkinson's disease. Researchers will look at brain imaging changes and compare them to motor and non-motor symptoms as well as cardiac function over time.See study design

What are the potential side effects?

While specific side effects are not listed here, Terazosin may cause dizziness due to its blood pressure-lowering effect. Other common side effects could include weakness or nasal congestion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I understand the details of the clinical trial and can consent to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in 123I-MIBG - Washout ratio (WR)

Changes in 123I-MIBG reuptake - early Heart to Mediastinal ratio (H/M)

Changes in 123I-MIBG reuptake - late Heart to Mediastinal ratio (H/M)

Secondary outcome measures

Changes in 123I-Ioflupane uptake

Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population

Heart Rate Variability Analysis (HRV) compared to MIBG results in predicting RBD conversion to PD/other synucleinopathies

+1 more

Other outcome measures

Central insulin resistance changes between baseline and every 6 months for three years

Color vision changes, as assessed using Hardy, Rand and Rittler (HRR) pseudoisochromatic Plates, between baseline and every 6 months for three years

Correlation between changes in integrity of pigmented neurons of substantia nigra as measured by neuromelanin-sensitive magnetic resonance imaging (MRI) and 123I-Ioflupane uptake as measured by Dopamine Transporter Imaging (DAT scan)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: terazosin therapy extensionExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,884 Total Patients Enrolled

Michele Tagliati, MD, FAANPrincipal InvestigatorCedars-Sinai Medical Center

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Terazosin (Alpha-1 Adrenergic Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05109364 — Phase 2

Parkinson's Disease Research Study Groups: terazosin therapy extension

Parkinson's Disease Clinical Trial 2023: Terazosin Highlights & Side Effects. Trial Name: NCT05109364 — Phase 2

Terazosin (Alpha-1 Adrenergic Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05109364 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the uppermost threshold of individuals involved in this experiment?

"Affirmative. According to information posted on clinicaltrials.gov, the medical trial is currently soliciting participants and was first published on September 23rd 2022. The study's protocol underwent its most recent revision on August 23rd 2022 and plans to enroll 15 patients at one location."

Answered by AI

What precedent has been set with regard to the efficacy of Terazosin therapy?

"Currently, Terazosin therapy is being explored in 3 live trials with 0 of these studies having reached the third phase. The majority of clinical research has taken place at Iowa City, but there are a few other centres exploring this therapeutic option."

Answered by AI

Has the U.S. Food and Drug Administration given its blessing to Terazosin treatment?

"While evidence of its efficacy is still being investigated, there are some studies that affirm terazosin's safety. Accordingly, it has been assigned a rating of 2 out of 3."

Answered by AI

Does this clinical trial include elderly individuals aged 75 or older?

"The minimum age to enroll in this medical trial is 25 and the maximum age permissible is 85. However, there are 133 trials specifically tailored for those under 18 years old and 703 studies that focus on individuals over 65."

Answered by AI

Are there any remaining vacancies in this clinical research effort?

"Affirmative. Clinicaltrials.gov informs us that recruitment for this medical trial, which was first made available on September 23rd 2022, is still ongoing and the details were most recently revised on August 23rd 2022. 15 participants must be sourced from a single site to complete the study's requirements."

Answered by AI

What criteria must a potential participant meet to be eligible for this research endeavor?

"Eligibility criteria for this trial demand that participants possess rem sleep behavior disorder and be between the ages of 25 to 85. There is space available for approximately 15 individuals."

Answered by AI