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NOT YET RECRUITING
NCT07288450
PHASE1/PHASE2

Terazosin And Metabolic Engagement in Parkinson's Disease

Sponsor: Nandakumar Narayanan

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09-01

Completion Date

2031-09-01

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DRUG

Terazosin Hydrochloride

TZ is an a1-adrenergic receptor antagonist that is FDA-approved to treat benign prostatic hyperplasia (BPH) and hypertension.

OTHER

Placebo

Placebo control for Terazosin