Symptomatic Parkinson DiseasePhase 2NCT05109364
Terazosin and Parkinson's Disease Extension Study
A Phase 2 study testing Terazosin therapy in people with Symptomatic Parkinson Disease and REM Sleep Behavior Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Symptomatic Parkinson Disease, REM Sleep Behavior Disorder, Pre-motor Parkinson's Disease
- What is being tested?
- Terazosin therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 10 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: The Effect of alpha1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up Study
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.
Read the 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.
- Being tested
- Terazosin therapy
- Keywords
- Parkinson's disease, REM sleep behavior disorder (RBD), Autonomic dysfunction, Neurodegeneration, Terazosin
- Medical subject headings
- Parkinson Disease, Secondary, REM Sleep Behavior Disorder, Parkinson Disease, Primary Dysautonomias, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terazosin therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| terazosin therapy extension | Experimental | 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. Receives: Drug: Terazosin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 123I-MIBG reuptake - early Heart to Mediastinal ratio (H/M)
123I-MIBG early reuptake will be measured by Heart to Mediastinal ratio (H/M) which will be calculated from the early images after drawing regions of interest (7×7 pixels) over the upper mediastinum and circular ROI around the entire heart. MIBG abnormality cutoff will be set for values of late H/M <2.2.
Measured: Every 6 months for 3 years
Changes in 123I-MIBG reuptake - late Heart to Mediastinal ratio (H/M)
123I-MIBG late reuptake will be measured by Heart to Mediastinal ratio (H/M) which will be calculated from the late images after drawing regions of interest (7×7 pixels) over the upper mediastinum and circular ROI around the entire heart. MIBG abnormality cutoff will be set for values of late H/M <2.2.
Measured: Every 6 months for 3 years
Changes in 123I-MIBG - Washout ratio (WR)
123I-MIBG Washout ratio (WR) will be calculated using the following formula: [(early heart counts/pixel - early mediastinum counts/pixel) - (late heart counts/pixel decay-corrected - late mediastinum counts/pixel decay-corrected)]/(early heart counts/pixel - early mediastinum counts/pixel). Care will be taken to exclude lung or liver from the myocardial and large vessels and lung from the mediastinum region of interest. MIBG abnormality cutoff will be set for values of WR >30%.
Measured: Every 6 months for 3 years
Secondary outcomes (4)
Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population
Diagnosis of PD will be defined or ruled out according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
Measured: 3 years
Changes in 123I-Ioflupane uptake
Measured by 123I-Ioflupane uptake, between baseline, year one, year two and year three.
Measured: Every year for three years
Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies
Integrity of pigmented neurons of substantia nigra.
Measured: 3 years
Heart Rate Variability Analysis (HRV) compared to MIBG results in predicting RBD conversion to PD/other synucleinopathies
Beat-to-beat intervals will be registered to assess sympatho-vagal balance. This measurement will be used for HRV analysis.
Measured: Every 6 months for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start23 Sep 2022
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (78)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tagliati, MD, Cedars-Sinai Medical Center
- Investigators
- Michele Tagliati, MD, FAAN, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109364
- Sponsor's protocol ID
- STUDY00001770
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2021
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Academy of Sleep Medicine. International classification of sleep disor- ders 2nd ed.: Diagnostic and coding manual. Westchester, IL: American Academy of Sleep Medicine; 2005.
Amino T, Orimo S, Itoh Y, Takahashi A, Uchihara T, Mizusawa H. Profound cardiac sympathetic denervation occurs in Parkinson disease. Brain Pathol. 2005 Jan;15(1):29-34. doi: 10.1111/j.1750-3639.2005.tb00097.x.
PubMed 15779234Boeve BF. REM sleep behavior disorder: Updated review of the core features, the REM sleep behavior disorder-neurodegenerative disease association, evolving concepts, controversies, and future directions. Ann N Y Acad Sci. 2010 Jan;1184:15-54. doi: 10.1111/j.1749-6632.2009.05115.x.
PubMed 20146689Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
PubMed 12498954Cai R, Zhang Y, Simmering JE, Schultz JL, Li Y, Fernandez-Carasa I, Consiglio A, Raya A, Polgreen PM, Narayanan NS, Yuan Y, Chen Z, Su W, Han Y, Zhao C, Gao L, Ji X, Welsh MJ, Liu L. Enhancing glycolysis attenuates Parkinson's disease progression in models and clinical databases. J Clin Invest. 2019 Oct 1;129(10):4539-4549. doi: 10.1172/JCI129987.
PubMed 31524631Cedarbaum JM, Aghajanian GK. Catecholamine receptors on locus coeruleus neurons: pharmacological characterization. Eur J Pharmacol. 1977 Aug 15;44(4):375-85. doi: 10.1016/0014-2999(77)90312-0. No abstract available.
PubMed 330174Chang EB, Leung PS. Gastrintestinal Motility. In 'The Gastrointestinal System: Gastrointestinal, Nutritional and Hepatobiliary Physiology' P.S. Leung (ed.), Springer Science, Dordrecht 2014, 35-62.
Clewett DV, Lee TH, Greening S, Ponzio A, Margalit E, Mather M. Neuromelanin marks the spot: identifying a locus coeruleus biomarker of cognitive reserve in healthy aging. Neurobiol Aging. 2016 Jan;37:117-126. doi: 10.1016/j.neurobiolaging.2015.09.019. Epub 2015 Oct 29.
PubMed 26521135de Milliano PA, van Eck-Smit BL, de Groot AC, Lie KI. Metoprolol-induced changes in myocardial (123)I-metaiodobenzylguanidine uptake in Parkinson's disease. Circulation. 2000 Nov 14;102(20):2553-4. doi: 10.1161/01.cir.102.20.2553. No abstract available.
PubMed 11076832de Peuter OR, Verberne HJ, Kok WE, van den Bogaard B, Schaap MC, Nieuwland R, Meijers JC, Somsen GA, Bakx A, Kamphuisen PW. Differential effects of nonselective versus selective beta-blockers on cardiac sympathetic activity and hemostasis in patients with heart failure. J Nucl Med. 2013 Oct;54(10):1733-9. doi: 10.2967/jnumed.113.120477. Epub 2013 Aug 22.
PubMed 23970363Dinan TG, Cryan JF. Regulation of the stress response by the gut microbiota: implications for psychoneuroendocrinology. Psychoneuroendocrinology. 2012 Sep;37(9):1369-78. doi: 10.1016/j.psyneuen.2012.03.007. Epub 2012 Apr 5.
PubMed 22483040Dorschner J, Farmakis G, Behnke S, Hellwig D, Schneider S, Fassbender K, Kirsch CM, Dillmann U, Spiegel J. Myocardial MIBG scintigraphy may predict the course of motor symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2011 Jun;17(5):372-5. doi: 10.1016/j.parkreldis.2011.03.001. Epub 2011 Mar 21.
PubMed 21421334Fereshtehnejad SM, Montplaisir JY, Pelletier A, Gagnon JF, Berg D, Postuma RB. Validation of the MDS research criteria for prodromal Parkinson's disease: Longitudinal assessment in a REM sleep behavior disorder (RBD) cohort. Mov Disord. 2017 Jun;32(6):865-873. doi: 10.1002/mds.26989. Epub 2017 Apr 21.
PubMed 28429825Goldstein DS, Holmes C, Li ST, Bruce S, Metman LV, Cannon RO 3rd. Cardiac sympathetic denervation in Parkinson disease. Ann Intern Med. 2000 Sep 5;133(5):338-47. doi: 10.7326/0003-4819-133-5-200009050-00009.
PubMed 10979878Gronich N, Abernethy DR, Auriel E, Lavi I, Rennert G, Saliba W. beta2-adrenoceptor agonists and antagonists and risk of Parkinson's disease. Mov Disord. 2018 Sep;33(9):1465-1471. doi: 10.1002/mds.108.
PubMed 30311974
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of alpha1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up Study
- ClinicalTrials.gov ID
- NCT05109364
- Acronym / sponsor ID
- STUDY00001770
- Keywords
- Parkinson's disease, REM sleep behavior disorder (RBD), Autonomic dysfunction, Neurodegeneration, Terazosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| terazosin therapy extension | Experimental | Drug: Terazosin therapyPrimary 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (25 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terazosin therapyPrimary 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. | Drug | terazosin therapy extension |
Primary outcome
Changes in 123I-MIBG reuptake - early Heart to Mediastinal ratio (H/M)
Time frame: Every 6 months for 3 years
123I-MIBG early reuptake will be measured by Heart to Mediastinal ratio (H/M) which will be calculated from the early images after drawing regions of interest (7×7 pixels) over the upper mediastinum and circular ROI around the entire heart. MIBG abnormality cutoff will be set for values of late H/M <2.2.
Changes in 123I-MIBG reuptake - late Heart to Mediastinal ratio (H/M)
Time frame: Every 6 months for 3 years
123I-MIBG late reuptake will be measured by Heart to Mediastinal ratio (H/M) which will be calculated from the late images after drawing regions of interest (7×7 pixels) over the upper mediastinum and circular ROI around the entire heart. MIBG abnormality cutoff will be set for values of late H/M <2.2.
Changes in 123I-MIBG - Washout ratio (WR)
Time frame: Every 6 months for 3 years
123I-MIBG Washout ratio (WR) will be calculated using the following formula: [(early heart counts/pixel - early mediastinum counts/pixel) - (late heart counts/pixel decay-corrected - late mediastinum counts/pixel decay-corrected)]/(early heart counts/pixel - early mediastinum counts/pixel). Care will be taken to exclude lung or liver from the myocardial and large vessels and lung from the mediastinum region of interest. MIBG abnormality cutoff will be set for values of WR >30%.
4 secondary outcomes
Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population
Time frame: 3 years
Changes in 123I-Ioflupane uptake
Time frame: Every year for three years
Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies
Time frame: 3 years
Heart Rate Variability Analysis (HRV) compared to MIBG results in predicting RBD conversion to PD/other synucleinopathies
Time frame: Every 6 months for 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Results publicationAmerican Academy of Sleep Medicine. International classification of sleep disor- ders 2nd ed.: Diagnostic and coding manual. Westchester, IL: American Academy of Sleep Medicine; 2005.
- Results publication: PubMed 15779234Amino T, Orimo S, Itoh Y, Takahashi A, Uchihara T, Mizusawa H. Profound cardiac sympathetic denervation occurs in Parkinson disease. Brain Pathol. 2005 Jan;15(1):29-34. doi: 10.1111/j.1750-3639.2005.tb00097.x.
- Results publication: PubMed 20146689Boeve BF. REM sleep behavior disorder: Updated review of the core features, the REM sleep behavior disorder-neurodegenerative disease association, evolving concepts, controversies, and future directions. Ann N Y Acad Sci. 2010 Jan;1184:15-54. doi: 10.1111/j.1749-6632.2009.05115.x.
- Results publication: PubMed 12498954Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.
- Results publication: PubMed 31524631Cai R, Zhang Y, Simmering JE, Schultz JL, Li Y, Fernandez-Carasa I, Consiglio A, Raya A, Polgreen PM, Narayanan NS, Yuan Y, Chen Z, Su W, Han Y, Zhao C, Gao L, Ji X, Welsh MJ, Liu L. Enhancing glycolysis attenuates Parkinson's disease progression in models and clinical databases. J Clin Invest. 2019 Oct 1;129(10):4539-4549. doi: 10.1172/JCI129987.
- Results publication: PubMed 330174Cedarbaum JM, Aghajanian GK. Catecholamine receptors on locus coeruleus neurons: pharmacological characterization. Eur J Pharmacol. 1977 Aug 15;44(4):375-85. doi: 10.1016/0014-2999(77)90312-0. No abstract available.
- Results publicationChang EB, Leung PS. Gastrintestinal Motility. In 'The Gastrointestinal System: Gastrointestinal, Nutritional and Hepatobiliary Physiology' P.S. Leung (ed.), Springer Science, Dordrecht 2014, 35-62.
- Results publication: PubMed 26521135Clewett DV, Lee TH, Greening S, Ponzio A, Margalit E, Mather M. Neuromelanin marks the spot: identifying a locus coeruleus biomarker of cognitive reserve in healthy aging. Neurobiol Aging. 2016 Jan;37:117-126. doi: 10.1016/j.neurobiolaging.2015.09.019. Epub 2015 Oct 29.
- Results publication: PubMed 11076832de Milliano PA, van Eck-Smit BL, de Groot AC, Lie KI. Metoprolol-induced changes in myocardial (123)I-metaiodobenzylguanidine uptake in Parkinson's disease. Circulation. 2000 Nov 14;102(20):2553-4. doi: 10.1161/01.cir.102.20.2553. No abstract available.
- Results publication: PubMed 23970363de Peuter OR, Verberne HJ, Kok WE, van den Bogaard B, Schaap MC, Nieuwland R, Meijers JC, Somsen GA, Bakx A, Kamphuisen PW. Differential effects of nonselective versus selective beta-blockers on cardiac sympathetic activity and hemostasis in patients with heart failure. J Nucl Med. 2013 Oct;54(10):1733-9. doi: 10.2967/jnumed.113.120477. Epub 2013 Aug 22.
- Results publication: PubMed 22483040Dinan TG, Cryan JF. Regulation of the stress response by the gut microbiota: implications for psychoneuroendocrinology. Psychoneuroendocrinology. 2012 Sep;37(9):1369-78. doi: 10.1016/j.psyneuen.2012.03.007. Epub 2012 Apr 5.
- Results publication: PubMed 21421334Dorschner J, Farmakis G, Behnke S, Hellwig D, Schneider S, Fassbender K, Kirsch CM, Dillmann U, Spiegel J. Myocardial MIBG scintigraphy may predict the course of motor symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2011 Jun;17(5):372-5. doi: 10.1016/j.parkreldis.2011.03.001. Epub 2011 Mar 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Tagliati, MD, FAAN principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terazosin therapy in people with Symptomatic Parkinson Disease and REM Sleep Behavior Disorder, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 123I-MIBG reuptake - early Heart to Mediastinal ratio (H/M) (time frame: Every 6 months for 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05109364, which also lists 78 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.