Parkinson's DiseasePhase 1/2TAME-PDNCT07288450
Terazosin And Metabolic Engagement in Parkinson's Disease
A Phase 1/2 study testing Terazosin Hydrochloride in people with Parkinson's Disease, run by Nandakumar Narayanan.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Terazosin Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2031
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Show all 16Show fewer
- 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.
About this study
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.
Read the detailed description
Terazosin (TZ) has the potential to be repurposed for use as the first disease-modifying treatment of Parkinson's disease (PD). This would have substantial implications for patients with PD and for society. TZ may provide a safe and low-cost treatment option for individuals with PD. If TZ proves beneficial for the treatment of PD, the proposed study design will efficiently facilitate the availability of a much-needed medication by reducing the time and costs typically associated with drug discovery. For these reasons, the study should be given high priority given the extremely favorable cost-to-benefit ratio.
Consistent with prior studies, subjects who have received a diagnosis of PD within the preceding three years and who are taking no more than two dopaminergic medications at the time of screening will be enrolled. This criterion ensures that the pharmacodynamics of TZ are assessed in a population most representative of the largest number of patients with PD.
Following randomization, patients will remain on therapy for 26 weeks. The extended duration of the study is intended to assess sustained target engagement of TZ in patients with PD.
Risk/Benefit Assessment TZ is associated with an increased risk of orthostatic hypotension. This risk is particularly relevant in PD, where the prevalence of orthostatic hypotension is significantly higher compared to healthy controls. Patients with PD are also more susceptible to falls, which could be exacerbated by orthostatic hypotension. Data from the Truven database demonstrated that patients with PD who were using TZ did not have a significantly increased prevalence of ICD-9 codes related to falls compared to PD patients not using TZ. These findings suggest that the risk of orthostatic hypotension is not elevated significantly at a population level, though it remains a concern for individual participants. Importantly, no serious adverse events were reported in a pilot study. Mild side effects such as dizziness and lightheadedness were more common in participants taking TZ, and dropout rates were higher in this group due to these side effects. Therefore, accounting for the potential for higher dropout rates is imperative. This provides the rationale for enrolling more subjects into the TZ group to ensure adequate statistical power even if dropout rates are elevated.
TZ is also associated with additional adverse effects, including peripheral edema, palpitations, nausea, asthenia, dizziness, headache, and somnolence. Despite these risks, the potential benefit of TZ is significant given the absence of currently available treatments that slow the progression of PD. The proposed study will provide critical insights into both short-term and sustained target engagement of TZ in patients with PD.
- Conditions
- Parkinson's Disease
- Being tested
- Terazosin Hydrochloride, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terazosin HydrochlorideDrug
TZ is an a1-adrenergic receptor antagonist that is FDA-approved to treat benign prostatic hyperplasia (BPH) and hypertension.
PlaceboOther
Placebo control for Terazosin
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | Terazosin hydrochloride Receives: Drug: Terazosin Hydrochloride |
| Placebo | Placebo comparator | Placebo control Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-blood ATP
Changes in the amount of ATP in the blood for patients taking Terazosin vs. Placebo.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Why it stopped: Not Funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary goal of this study is to assess target engagement of TZ at varying doses of TZ. Specifically, we wish to identify a dose of TZ that provides optimal pharmacodynamic effect in patients with PD and to determine if this effect can be sustained for 6 months. By incorporating multiple assays of target engagement during a slow titration of TZ, we will be able to efficiently study target engagement at multiple doses using a multi-modal approach. We will also be able to assess the relationship between target engagement in the brain and the blood assays.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nandakumar Narayanan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nandakumar Narayanan, University of Iowa
- Investigators
- Nandakumar Narayanan, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288450
- Sponsor's protocol ID
- TAMEPD
- Acronym
- TAME-PD
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share demographic details, details on Parkinson's disease, and then details on whole-blood ATP and Terazosin.
Publications
Schultz JL, Gander PE, Workman CD, Ponto LL, Cross S, Nance CS, Groth CL, Taylor EB, Ernst SE, Xu J, Uc EY, Magnotta VA, Welsh MJ, Narayanan NS. A pilot dose-finding study of Terazosin in humans. medRxiv [Preprint]. 2024 May 22:2024.05.22.24307622. doi: 10.1101/2024.05.22.24307622.
PubMed 38826433Hart A, Aldridge G, Zhang Q, Narayanan NS, Simmering JE. Association of Terazosin, Doxazosin, or Alfuzosin Use and Risk of Dementia With Lewy Bodies in Men. Neurology. 2024 Jul 23;103(2):e209570. doi: 10.1212/WNL.0000000000209570. Epub 2024 Jun 19.
PubMed 38896813Schultz JL, Gander PE, Workman CD, Boles Ponto LL, Cross S, Nance CS, Groth CL, Taylor EB, Ernst SE, Xu J, Uc EY, Magnotta VA, Welsh MJ, Narayanan NS. A dose-finding study shows terazosin enhanced energy metabolism in neurologically healthy adults. J Parkinsons Dis. 2025 Nov;15(7):1253-1263. doi: 10.1177/1877718X251356503. Epub 2025 Aug 10.
PubMed 40785306
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terazosin And Metabolic Engagement in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07288450
- Acronym / sponsor ID
- TAME-PD / TAMEPD
- Conditions
- Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not Funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nandakumar NarayananUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 17 Dec 2025 (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.
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.
Detailed description
Terazosin (TZ) has the potential to be repurposed for use as the first disease-modifying treatment of Parkinson's disease (PD). This would have substantial implications for patients with PD and for society. TZ may provide a safe and low-cost treatment option for individuals with PD. If TZ proves beneficial for the treatment of PD, the proposed study design will efficiently facilitate the availability of a much-needed medication by reducing the time and costs typically associated with drug discovery. For these reasons, the study should be given high priority given the extremely favorable cost-to-benefit ratio.
Consistent with prior studies, subjects who have received a diagnosis of PD within the preceding three years and who are taking no more than two dopaminergic medications at the time of screening will be enrolled. This criterion ensures that the pharmacodynamics of TZ are assessed in a population most representative of the largest number of patients with PD.
Following randomization, patients will remain on therapy for 26 weeks. The extended duration of the study is intended to assess sustained target engagement of TZ in patients with PD.
Risk/Benefit Assessment TZ is associated with an increased risk of orthostatic hypotension. This risk is particularly relevant in PD, where the prevalence of orthostatic hypotension is significantly higher compared to healthy controls. Patients with PD are also more susceptible to falls, which could be exacerbated by orthostatic hypotension. Data from the Truven database demonstrated that patients with PD who were using TZ did not have a significantly increased prevalence of ICD-9 codes related to falls compared to PD patients not using TZ. These findings suggest that the risk of orthostatic hypotension is not elevated significantly at a population level, though it remains a concern for individual participants. Importantly, no serious adverse events were reported in a pilot study. Mild side effects such as dizziness and lightheadedness were more common in participants taking TZ, and dropout rates were higher in this group due to these side effects. Therefore, accounting for the potential for higher dropout rates is imperative. This provides the rationale for enrolling more subjects into the TZ group to ensure adequate statistical power even if dropout rates are elevated.
TZ is also associated with additional adverse effects, including peripheral edema, palpitations, nausea, asthenia, dizziness, headache, and somnolence. Despite these risks, the potential benefit of TZ is significant given the absence of currently available treatments that slow the progression of PD. The proposed study will provide critical insights into both short-term and sustained target engagement of TZ in patients with PD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The primary goal of this study is to assess target engagement of TZ at varying doses of TZ. Specifically, we wish to identify a dose of TZ that provides optimal pharmacodynamic effect in patients with PD and to determine if this effect can be sustained for 6 months. By incorporating multiple assays of target engagement during a slow titration of TZ, we will be able to efficiently study target engagement at multiple doses using a multi-modal approach. We will also be able to assess the relationship between target engagement in the brain and the blood assays.
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Drug: Terazosin HydrochlorideTerazosin hydrochloride |
| Placebo | Placebo comparator | Other: PlaceboPlacebo control |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- • 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.
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 HydrochlorideTZ is an a1-adrenergic receptor antagonist that is FDA-approved to treat benign prostatic hyperplasia (BPH) and hypertension. | Drug | Active arm |
| PlaceboPlacebo control for Terazosin | Other | Placebo |
Primary outcome
Whole-blood ATP
Time frame: 1 year
Changes in the amount of ATP in the blood for patients taking Terazosin vs. Placebo.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 38826433Schultz JL, Gander PE, Workman CD, Ponto LL, Cross S, Nance CS, Groth CL, Taylor EB, Ernst SE, Xu J, Uc EY, Magnotta VA, Welsh MJ, Narayanan NS. A pilot dose-finding study of Terazosin in humans. medRxiv [Preprint]. 2024 May 22:2024.05.22.24307622. doi: 10.1101/2024.05.22.24307622.
- Background: PubMed 38896813Hart A, Aldridge G, Zhang Q, Narayanan NS, Simmering JE. Association of Terazosin, Doxazosin, or Alfuzosin Use and Risk of Dementia With Lewy Bodies in Men. Neurology. 2024 Jul 23;103(2):e209570. doi: 10.1212/WNL.0000000000209570. Epub 2024 Jun 19.
- Background: PubMed 40785306Schultz JL, Gander PE, Workman CD, Boles Ponto LL, Cross S, Nance CS, Groth CL, Taylor EB, Ernst SE, Xu J, Uc EY, Magnotta VA, Welsh MJ, Narayanan NS. A dose-finding study shows terazosin enhanced energy metabolism in neurologically healthy adults. J Parkinsons Dis. 2025 Nov;15(7):1253-1263. doi: 10.1177/1877718X251356503. Epub 2025 Aug 10.
- Individual participant dataSharing planned: Yes. We will share demographic details, details on Parkinson's disease, and then details on whole-blood ATP and Terazosin.
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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.
Nandakumar Narayanan principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Terazosin Hydrochloride in people with Parkinson's Disease, run by Nandakumar Narayanan.
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 4 inclusion and 16 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: withdrawn, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Whole-blood ATP (time frame: 1 year). 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 NCT07288450, which also lists 3 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 7 Oct 2026.