15 Participants Needed

Terazosin for Early Parkinson's Disease

Recruiting at 1 trial location
GO
ML
GO
MK
Overseen ByMaryClare Kelly
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using alpha-adrenergic antagonists or certain medications like sildenafil, tadalafil, or vardenafil.

Is Terazosin safe for humans?

There is no specific safety data for Terazosin in the provided research articles.12345

How does the drug Terazosin differ from other treatments for Parkinson's disease?

Terazosin, primarily used for high blood pressure and enlarged prostate, is being explored for Parkinson's disease due to its potential to improve cellular energy production, which is a novel approach compared to traditional treatments that mainly focus on dopamine replacement.678910

What data supports the effectiveness of the drug Terazosin for treating early Parkinson's Disease?

Terazosin has been shown to be effective in treating conditions like hypertension (high blood pressure) and benign prostatic hyperplasia (BPH), where it improves urine flow and reduces symptoms. While these conditions are different from Parkinson's Disease, the drug's ability to improve blood flow and reduce symptoms in other conditions may suggest potential benefits for Parkinson's patients.1112131415

Who Is on the Research Team?

ML

Michele L Tagliati, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with a specific sleep disorder related to dreaming.
I have been diagnosed with a specific sleep disorder involving acting out dreams.
I am between 50 and 85 years old.
See 3 more

Exclusion Criteria

I have Parkinson's disease symptoms not caused by primary Parkinson's.
You have a condition called dementia, as determined by a test score lower than 22 on the MOCA.
I have severe depression with a BDI score over 13.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral doses of adrenergic blocker terazosin, titrated from 1 mg to 5 mg or 10 mg based on tolerability

26 weeks
Weekly visits for dose titration, followed by regular monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including heart rate variability and MIBG reuptake

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Terazosin
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: terazosin therapyExperimental Treatment1 Intervention

Terazosin is already approved in United States for the following indications:

🇺🇸
Approved in United States as Hytrin for:
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Approved in United States as Tezruly for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

Published Research Related to This Trial

Terazosin is a selective alpha 1-adrenoceptor blocker that effectively lowers blood pressure and can be taken once daily due to its long half-life, making it convenient for patients with mild-to-moderate hypertension.
It has a significant advantage over prazosin due to its greater water solubility and longer duration of action, and it is safe to use in combination with other antihypertensive medications.
Terazosin: a new alpha adrenoceptor blocking drug.Achari, R., Laddu, A.[2019]
In a pilot study involving 15 patients with benign prostatic hyperplasia (BPH), terazosin significantly improved both peak and mean urine flow rates, as well as reduced residual urine volume and obstructive symptoms (p < 0.001).
These preliminary results suggest that terazosin is an effective treatment option for alleviating symptoms associated with BPH, supporting its therapeutic value in managing this condition.
Effects of terazosin in the treatment of benign prostatic hyperplasia. A pilot study.Dunzendorfer, U.[2013]
In a 6-month study comparing terazosin and enalapril, both antihypertensive medications showed similar effectiveness, with about 60% of patients continuing their prescriptions.
The differences in prescribing patterns were influenced more by marketing strategies and physician perceptions than by any significant clinical differences between the two drugs.
Prescribing and usage patterns of two antihypertensive agents: a comparison of terazosin and enalapril.Toiber, F., Murthy, VS.[2015]

Citations

Terazosin: a new alpha adrenoceptor blocking drug. [2019]
Effects of terazosin in the treatment of benign prostatic hyperplasia. A pilot study. [2013]
Prescribing and usage patterns of two antihypertensive agents: a comparison of terazosin and enalapril. [2015]
Prospective evaluation of terazosin for the treatment of autonomic dysreflexia. [2019]
Terazosin: a new alpha 1-blocker for the treatment of hypertension: a review of randomized, controlled clinical trials of once-daily administration as monotherapy. [2013]
Tegaserod in constipation associated with Parkinson disease. [2012]
Metabotropic glutamate receptor 5 antagonist protects dopaminergic and noradrenergic neurons from degeneration in MPTP-treated monkeys. [2023]
Rotigotine transdermal patch in Parkinson's disease: a systematic review and meta-analysis. [2021]
Transdermal rotigotine in early stage Parkinson's disease: a randomized, double-blind, placebo-controlled trial. [2017]
Antidepressant-like properties of sarizotan in experimental Parkinsonism. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Antidyskinetic effect of A2A and 5HT1A/1B receptor ligands in two animal models of Parkinson's disease. [2017]
Activity of serotonin 5-HT(1A) receptor 'biased agonists' in rat models of Parkinson's disease and L-DOPA-induced dyskinesia. [2015]
Contribution of brain serotonin subtype 1B receptors in levodopa-induced motor complications. [2016]
Eltoprazine counteracts l-DOPA-induced dyskinesias in Parkinson's disease: a dose-finding study. [2018]
Effect of the selective 5-HT2A receptor antagonist EMD-281,014 on L-DOPA-induced abnormal involuntary movements in the 6-OHDA-lesioned rat. [2020]
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