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STUDY00001770

Terazosin and parkinson's disease extension study
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT05109364
Parkinson's disease
REM sleep behavior disorder (RBD)
Autonomic dysfunction
Neurodegeneration
Terazosin
Source :Importé depuis le centre
Symptomatic Parkinson Disease
REM Sleep Behavior Disorder
Pre-motor Parkinson's Disease
Recrutement fermé
Dernière modification : 2026/03/01
Type de recherche

Interventionnel

Médicament expérimental

PHASE2


Population cible

Condition médicale (spécialité visée)

Choix aire thérapeutique

Symptomatic Parkinson Disease

REM Sleep Behavior Disorder

Pre-motor Parkinson's Disease

Source : Importé depuis le centre

Profil des participants

Limites d'âge
minimum : 50 ans maximum : 85 ans
Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
terazosin therapy extension 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. Donnée non disponible
  • Inconnu
  • terazosin therapy extension
    État du recrutement
    unknown
    Données à jour depuis : 1 mars 2026

    Description de l'étude

    Résumé de l'étude

    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.

    Source : Importé depuis le centre

    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.

    Source : Importé depuis le centre

    Sites

    Centres participants

      1 centres
    • CEDARS SINAI MEDICAL CENTER

      Los angeles

      CALIFORNIA, UNITED STATES

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 1 mars 2026
    Données à jour depuis : 3 mars
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT05109364