Terazosin for Dementia With Lewy Bodies

Launched by QIANG ZHANG · Feb 15, 2021

Keywords

ClinConnect Summary

The TZ-DLB trial is a research study looking at a medication called terazosin to see how well it can be tolerated by people with dementia with Lewy bodies. This type of dementia can cause memory problems, confusion, and changes in behavior. In this trial, participants will be randomly assigned to receive either terazosin or a placebo (a harmless substance with no active medicine) to compare the effects.

To be eligible for this study, participants must have a diagnosis of dementia with Lewy bodies and a certain level of cognitive ability, as measured by a test called the MOCA. They also need to be stable on certain medications for at least a month. It’s important to know that not everyone can participate; for example, individuals with certain serious medical or mental health conditions may be excluded. Participants can expect regular check-ups throughout the study to monitor how they are doing with the treatment. This trial is not yet recruiting, meaning they haven't started enrolling participants yet, but it aims to gather important information about terazosin for future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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