NCT07288450Visszavonva1/2. fázis
Terazosin And Metabolic Engagement in Parkinson's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 7.
Rövid összefoglaló (regiszter, angolul)
To assess target engagement of terazosin (TZ) at multiple doses (1 mg/day, 3 mg/day, and 5 mg/day) and to assess sustained target engagement over 6 months relative to placebo in patients with Parkinson's Disease (PD). Target engagement will be measured using a whole blood luminescence assay to quantify Adenosine Triphosphate (ATP) and a plasma metabolomics assay. A subset of randomized participants will also undergo imaging studies to quantify cerebral ATP using 31P-magnetic resonance spectroscopy (31P-MRS) and 18F-fluurodeoxyglucosed positron emission tomography (18F-FDG PET) to assess changes in glucose uptake in response to TZ. The investigators will compare the mean change from baseline in these assays between the TZ and placebo groups. The null hypothesis to be tested is that TZ does not engage its target (phosphoglycerate kinase 1, or PGK1) and does not lead to increases in the outcome variables of interest. A total of 100 patients with early PD will be recruited. Participants will be randomized to TZ or placebo in a 60:40 fashion to account for predicted dropouts in the TZ group. Study treatment will be administered for 26 weeks, followed by a four-week washout period.
- Állapot (regiszter)
- Visszavonva
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2025. dec. 15.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2030. szept. 1.
- Fő szponzor
- Nandakumar Narayanan
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07288450
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- • Orthostatic hypotension at screening is defined as decrease in BP \> 20 mmHg systolic or \> 10 mmHg diastolic and HR increase \<20 bpm on transition from supine to sitting or standing.
- Known allergy or previous adverse reaction to TZ or related compounds.
- Current use of TZ or concurrent use of DZ, AZ, prazosin, or tamsulosin.
- History of hepatic dysfunction.
- History of clinically relevant anemia.
- Secondary parkinsonism, drug-induced parkinsonism, Parkinson's-plus syndromes, or non-idiopathic PD.
- PD including use of more than two dopaminergic medications at screening.
- History of deep brain stimulation.
- Dementia per Movement Disorder Society Level 1 criteria.
- Traumatic brain injury or post-traumatic stress disorder.
- Presence of a confounding acute or unstable medical, psychiatric, or orthopedic condition.
- Unstable use of medications that modulate the central nervous system.
- Uncontrolled major depression or bipolar affective disorder, or other mental health disorders that are, in the opinion of the site investigator, sufficiently severe to increase risk of experiencing an Adverse Drug Reaction (ADR).
- Current suicidal ideation as measured by questions 4 or 5 of the Columbia-Suicide Severity Rating Scale.
- Participants with insufficient decisional capacity to provide written informed consent determined by the site investigator.
- Unstable use of antihypertensive medications.
Kiket keres a vizsgálat
- 50-80 years old at the time of enrollment with a diagnosis of idiopathic PD per the Movement Disorder Society's Diagnostic Criteria.
- Subjects must NOT be taking more than 2 dopaminergic treatments for their PD at the time of enrollment.
- Practically defined OFF Hoehn and Yahr score of 0-2.
- Diagnosis of PD made within the preceding 3 years.
Életkor a regiszterben: 40 év – 90 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.