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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].
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and at 26 weeks after medication titration
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Heart Rate variability changes from baseline at 26 weeks after study medication titration
Incidence of abnormal vital signs
Incidence of adverse events
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.
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,848 Total Patients Enrolled
Michele L Tagliati, MDPrincipal InvestigatorCedars-Sinai Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 been diagnosed with a specific sleep disorder related to dreaming.I have severe depression with a BDI score over 13.You have had a heart attack recently, ongoing chest pain, or certain heart conditions. You are breastfeeding, taking certain medications, or have certain medical conditions. If you are a woman, you are pregnant or planning to get pregnant during the study period, or have allergies to iodine or the study medication.I have been diagnosed with a specific sleep disorder involving acting out dreams.I am between 50 and 85 years old.I have at least one of the following: reduced sense of smell, constipation, color vision issues, depression, or abnormal heart scan.I have conditions like heart issues, high blood pressure, diabetes, or severe sleep apnea.You have severe constipation, as shown by a high score on a specific questionnaire about constipation symptoms.I am experiencing symptoms of depression or am currently taking antidepressants.
Research Study Groups:
This trial has the following groups:- Group 1: terazosin therapy
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you list some of the possible side effects associated with Terazosin?
"There is some evidence backing Terazosin's safety, but none for efficacy, so it was given a 2."
Answered by AI
Is the age limit for this research project set at 75 years or younger?
"The age requirement for participants in this trial is that they must be over 25 but younger than 85."
Answered by AI
Are we enrolling new participants in this research project at this time?
"That is correct. If you refer to the information available on clinicaltrials.gov, you will see that this study has been actively recruiting since November 1st 2020. The trial is looking for 15 patients at a single site."
Answered by AI
Could I possibly join this research project?
"This study is looking for 15 participants that suffer from RBD and are between the ages of 25-85. Most importantly, patients must meet the following criteria: Be Male or female of age between 25 and 85 years at time of enrollment., Have a 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"
Answered by AI
Could you provide more context on Terazosin's role in research?
"Terazosin is being trialed in 3 different active studies, none of which have reached Phase 3 yet. Most of the research surrounding Terazosin is taking place in Los Angeles, though there are 3 centres running trials for this medication across America."
Answered by AI
How many individuals are being asked to participate in this clinical trial?
"That is accurate. The listing on clinicaltrials.gov specifies that this particular trial is currently seeking participants. This research project was first made public on November 1st, 2020 and the most recent update occurred on August 23rd, 2022. They are looking for 15 individuals total across a single site."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Cedars Sinai Medical Center
Michele L Lima Gregorio
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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