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Alpha-1 Adrenergic Receptor Antagonist

Terazosin for Early Parkinson's Disease

Phase 2

Recruiting

Led By Michele L Tagliati, MD

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

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 or 'probable RBD' following a score of 6 or higher in the RBD questionnaire (RBDSQ), with a score of at least 1 in subitems 6.1 to 6.4 of question 6

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].

Must not have

Concurrent severe depression defined by a BDI fast screen score greater than 13

Secondary Parkinsonism, including tardive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 26 weeks after medication titration

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial will test whether the drug terazosin can help prevent Parkinson's disease in people who are at risk for the disease.

Who is the study for?

This trial is for people aged 50-85 with early signs of Parkinson's Disease, like REM Sleep Behavior Disorder or loss of smell. They must have constipation and may have depression but can't be severely depressed or demented. Participants need a specific heart scan result and can't have other serious health issues like recent heart attacks, very low blood pressure, severe sleep apnea, or diabetes.

What is being tested?

The study tests Terazosin's effect on the hearts of those at risk for Parkinson's. It looks at how this blood pressure medication might influence certain heart-related changes seen in early Parkinson’s stages by using special imaging techniques and comparing them to symptoms severity.

What are the potential side effects?

Terazosin could cause dizziness due to lowered blood pressure, especially when standing up quickly (orthostatic hypotension), fatigue, swollen limbs from fluid buildup (peripheral edema), headache, palpitations (feeling your heartbeat), and possibly priapism (a prolonged erection).

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a specific sleep disorder related to dreaming.

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I have been diagnosed with a specific sleep disorder involving acting out dreams.

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I am between 50 and 85 years old.

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I am experiencing symptoms of depression or am currently taking antidepressants.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe depression with a BDI score over 13.

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I have Parkinson's disease symptoms not caused by primary Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 26 weeks after medication titration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 26 weeks after medication titration

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 26 weeks after medication titration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Differences in 123I-MIBG reuptake, as measured by early and late Heart to mediastinum (H/M) ratio, and Washout Ration (WR), at 26 weeks of treatment with the adrenergic blocker terazosin

Secondary study objectives

Heart Rate variability changes from baseline at 26 weeks after study medication titration

Incidence of abnormal vital signs

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: terazosin therapyExperimental Treatment1 Intervention

Daily oral doses of adrenergic blocker 5 mg or 10 mg. The dosage will be gradually increased from the initial recommended starting dose of 1 mg daily at bedtime and titrated stepwise to 2mg, 5mg or 10 mg weekly, according to patient tolerability, as measured by subjective complaints, arterial blood pressure and heart rate. The target dose will be 5 mg or 10 mg daily based on subject's tolerability.

0 / 6Eligibility criteria met