Status:
NOT_YET_RECRUITING
Terazosin for Dementia With Lewy Bodies
Lead Sponsor:
Qiang Zhang
Conditions:
Dementia With Lewy Bodies
Eligibility:
All Genders
Up to 90 years
Phase:
PHASE1
PHASE2
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
October 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04760860
Start Date
October 1 2026
End Date
December 1 2028
Last Update
February 10 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52252