NCT04760860Not yet recruitingPhase 1/2
Terazosin for Dementia With Lewy Bodies
a Randomized, Double Blind, Placebo Controlled Clinical Trial Exploring the Target Engagement and Tolerability of Terazosin Hydrochloride in Patients With Dementia With Lewy Bodies
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Feb 2021
- Start date
- 1 Oct 2027
- Primary completion date
- 31 Oct 2030
- Lead sponsor
- Qiang Zhang
- Diseases
- Lewy body dementia
- NCT number
- NCT04760860
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Oct 2027 to the primary completion date, 31 Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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
Other illness
- Clinically significant traumatic brain injury or post-traumatic stress disorder
Age
- 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.
Other
- Subjects unwilling or unable to give informed consent
- 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.
- Presence of other known medical comorbidities that in the investigator's opinion would compromise participation in the study
- 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
Who the study is looking for
- 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.
Age in the registry: 0 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.