Terazosin And Metabolic Engagement in Parkinson's Disease

Sponsor
Nandakumar Narayanan
Study ID
NCT07288450
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Terazosin Hydrochloride — DRUG
    TZ is an a1-adrenergic receptor antagonist that is FDA-approved to treat benign prostatic hyperplasia (BPH) and hypertension.
  • Placebo — OTHER
    Placebo control for Terazosin

Study Details

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 Dates

First listed
Dec 17, 2025
Start date
Sep 1, 2026
Status verified
Dec 2025
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active arm
    Terazosin hydrochloride
  • Placebo Comparator: Placebo
    Placebo control

Primary Outcome Measure

Whole-blood ATP [ Time Frame: 1 year ]

Central Contacts

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