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Dementia With Lewy BodiesPhase 1/2TZ-DLBNCT04760860

Terazosin for Dementia With Lewy Bodies

A Phase 1/2 study testing Terazosin Hydrochloride in people with Dementia With Lewy Bodies, run by Qiang Zhang at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The TZ-DLB trial will be a 3:2 (active:placebo) randomized, double-blind, placebo-controlled Pilot trial to evaluate the tolerability of terazosin for the treatment of dementia with Lewy bodies. Read more about this study

Who is it for?
Ages 0 to 90 years
Conditions the study is for
Dementia With Lewy Bodies
What is being tested?
Terazosin Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2027to Dec 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 0 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Men or women with the diagnosis of dementia with Lewy Bodies per 2017 DLB Consortium criteria.
  • Baseline MOCA 18 or above. On stable AChEI and/or memantine treatment regimen for ≥4 weeks prior to baseline.

Who cannot join

  • Subjects unwilling or unable to give informed consent
  • No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days.
  • Orthostatic hypotension defined as symptomatic decrease in BP > 20mmHg systolic or > 10mmHg diastolic on supine to sitting or standing, or a sitting blood pressure of ≤90/60.
  • Clinically significant traumatic brain injury or post-traumatic stress disorder
  • Presence of other known medical comorbidities that in the investigator's opinion would compromise participation in the study
  • Psychiatric comorbidities including major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neurology assessment in the opinion of the responsible site principal investigator. Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit. Current suicidal ideation within one year prior to the baseline visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit.
Show all 11Show fewer
  • Use of investigational drugs within 30 days before screening
  • Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit
  • Use of doxazosin, alfuzosin, prazosin, or tamsulosin
  • For female participant, pregnancy, or plans for child-bearing during study period
  • Participant is restricted from traveling to and from the study site

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

qiang zhang, MD contact

4154251369

qiang-zhang@uiowa.edu

Jordan Schultz, Pharm D contact

jordan-schultz@uiowa.edu

United States1 site

  • University of Iowa

    Iowa City, Iowa, 52252

    qiang zhang, MD, qiang-zhang@uiowa.edu

    Jordan Schultz, PharmD, jordan-schultz@uiowa.edu

Other trials in United States

About this study

Official title: a Randomized, Double Blind, Placebo Controlled Clinical Trial Exploring the Target Engagement and Tolerability of Terazosin Hydrochloride in Patients With Dementia With Lewy Bodies

The TZ-DLB trial will be a 3:2 (active:placebo) randomized, double-blind, placebo-controlled Pilot trial to evaluate the tolerability of terazosin for the treatment of dementia with Lewy bodies.

Read the detailed description

This will be a single center, randomized, double-blind, placebo-controlled, pilot study to assess the tolerability of terazosin (TZ) at 1 and 5 milligrams (MG) daily for patients with DLB. The primary goal of this study is to assess the tolerability of TZ in patients with DLB. This is a pilot study and is not powered to assess efficacy of this medication. Our hope is that this study will guide future studies of this (and similar) medications for the disease modification of DLB. This study is also aimed to learn more about how patients with produce and use energy and if TZ can help to reverse energy deficits that appear in DLB.

Being tested
Terazosin Hydrochloride, Placebo
Medical subject headings
Lewy Body Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Terazosin HydrochlorideDrug

    Also called Terazosin, Hytrin

    In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the Terazosin group will receive Terazosin hydrochloride treatment for 15 weeks. Participants will start at 1mg daily for the first 6 week, then the dosage will be increased to 5mg daily over 3 weeks, and continued for the last 6 weeks.

  • PlaceboOther

    In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the control group will receive placebo for 15 weeks.

Study groups in NCT04760860
Study groupRoleWhat they receive
Placebo Control ArmPlacebo comparatorParticipants in this arm will receive placebo during the trial for 15 weeks, the placebo will follow the same schedule as the Terazosin group; the placebo capsules will have the same appearance as the Terazosin capsules.
Receives: Other: Placebo
Terazosin ArmExperimentalParticipants in this arm will receive Terazosin during the trial for 15 weeks. Participants will start at 1mg daily for the first 6 week, then the dosage will be increased to 5mg daily over 3 weeks, and continued for the last 6 weeks.
Receives: Drug: Terazosin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intervention-related adverse events between treatment arms

    All patient-reported adverse events will be compared.

    Measured: 15 weeks

  2. Frequency of drop-out/discontinuation of study intervention for any reason

    The number of participants in each group who drop out of the study for any reason will be compared.

    Measured: 15 weeks

  3. Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy

    Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy

    Measured: at baseline, 6 weeks and 15 weeks

Secondary outcomes (9)

  1. To assess the mean change in systolic and diastolic blood pressures

    Blood pressure will be evaluated at baseline, 2 weeks, 6 weeks and 12 weeks

    Measured: at baseline, 6 weeks and 15 weeks

  2. Unified Parkinson Disease Rating Scale (UPDRS) part III Motor examination

    Unified Parkinson Disease Rating Scale (UPDRS) part III will be evaluated at baseline, 2 weeks, 6 weeks and 12 weeks

    Measured: at baseline, 6 weeks and 15 weeks

  3. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

    Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be evaluated at baseline and 12 weeks

    Measured: at baseline, 6 weeks and 15 weeks

  4. Montreal Cognitive Assessment

    Montreal Cognitive Assessment

    Measured: at baseline, 6 weeks and 15 weeks

  5. The Clinician Interview-Based Impression of Change, plus carer interview (CIBIC-Plus)

    CIBIC-Plus will be evaluated at baseline and at 12 weeks

    Measured: at baseline, 6 weeks and 15 weeks

  6. Neuropsychiatric inventory

    NPI will be evaluated at baseline and at 12 weeks

    Measured: at baseline, 6 weeks and 15 weeks

  7. Fluorodeoxyglucose (FDG)-positron emission tomography (PET)

    A surrogate for glucose metabolism in the brain

    Measured: at baseline, 6 weeks and 15 weeks

  8. Serum ATP levels

    Serum ATP level changes will be compared between the TZ and the placebo arms

    Measured: at baseline, 6 weeks and 15 weeks

  9. Serum TeraZosin levels

    Serum Terazosin levels will be analyzed and a correlation between ATP levels and TZ levels will be evaluated

    Measured: at baseline, 6 weeks and 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study startOct 2027 (estimated)
  3. Primary completionOct 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04760860
Sponsor's protocol ID
202101470
Acronym
TZ-DLB
Status last verified
Mar 2026
First submitted
15 Feb 2021
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.

Publications

  • Cai R, Zhang Y, Simmering JE, Schultz JL, Li Y, Fernandez-Carasa I, Consiglio A, Raya A, Polgreen PM, Narayanan NS, Yuan Y, Chen Z, Su W, Han Y, Zhao C, Gao L, Ji X, Welsh MJ, Liu L. Enhancing glycolysis attenuates Parkinson's disease progression in models and clinical databases. J Clin Invest. 2019 Oct 1;129(10):4539-4549. doi: 10.1172/JCI129987.

    PubMed 31524631

  • Simmering JE, Welsh MJ, Liu L, Narayanan NS, Pottegard A. Association of Glycolysis-Enhancing alpha-1 Blockers With Risk of Developing Parkinson Disease. JAMA Neurol. 2021 Apr 1;78(4):407-413. doi: 10.1001/jamaneurol.2020.5157.

    PubMed 33523098

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Terazosin Hydrochloride in people with Dementia With Lewy Bodies, run by Qiang Zhang at 1 site in United States.

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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact qiang zhang, MD (4154251369, qiang-zhang@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intervention-related adverse events between treatment arms (time frame: 15 weeks). The study lists 3 primary outcomes in all. 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 NCT04760860, which also lists 2 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 12 Mar 2026.

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