Terazosin for Lewy Body Dementia
(TZ-DLB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether terazosin, a medication, is safe and tolerable for people with dementia with Lewy bodies, a condition affecting memory and thinking. Participants will receive either terazosin or a placebo (a pill with no active medication) for 15 weeks. Suitable candidates must have a diagnosis of dementia with Lewy bodies, a stable treatment plan for at least four weeks, and no uncontrolled medical conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires that participants be on a stable treatment regimen for certain medications, like those for dementia and central nervous system conditions, for at least 30 days before starting. However, you cannot use certain medications like doxazosin, alfuzosin, prazosin, or tamsulosin.
Is there any evidence suggesting that terazosin hydrochloride is likely to be safe for humans?
Research has shown that terazosin, a drug commonly used for prostate problems, might reduce the risk of developing dementia with Lewy bodies. Because this drug has been used for other conditions, researchers have some understanding of its safety. Other studies have generally found terazosin to be well-tolerated, with few serious side effects reported.
Terazosin's past use for prostate issues suggests that most people can take it without major problems. Common side effects are usually mild, such as dizziness or tiredness. However, not everyone experiences these effects, and they may decrease over time.
As this trial is in its early stages, the main goal is to assess how well people tolerate the drug. Early trials often focus on safety, so researchers closely monitor participants for any side effects. This helps ensure any issues are quickly addressed.12345Why do researchers think this study treatment might be promising for Lewy body dementia?
Terazosin is unique for treating Lewy Body Dementia because it takes a novel approach by potentially improving blood flow and energy production in brain cells. While current treatments like cholinesterase inhibitors and antipsychotics focus on managing symptoms, Terazosin targets cellular energy deficits, which could directly impact the progression of the disease. Researchers are excited about Terazosin because it offers a fresh perspective on tackling the underlying causes of neuronal decline, rather than just alleviating symptoms.
What evidence suggests that terazosin might be an effective treatment for Lewy body dementia?
Research has shown that terazosin, a drug commonly used for prostate problems, might help lower the risk of dementia with Lewy bodies (DLB). Several studies have found that people taking terazosin and similar drugs are less likely to develop DLB, suggesting that terazosin might protect against this type of dementia. In this trial, participants will divide into two groups: one will receive terazosin, and the other will receive a placebo. Although this trial primarily focuses on the drug's tolerability, current evidence hints at its potential to reduce the risk of DLB.23678
Who Is on the Research Team?
Nandakumar Narayanan, MD, PhD
Principal Investigator
University of Iowa
Are You a Good Fit for This Trial?
This trial is for men and women diagnosed with dementia with Lewy bodies who are on a stable treatment of AChEI/memantine for at least 4 weeks, have a MOCA score of 18 or above, and meet specific diagnostic criteria. Excluded are those with serious medical conditions, unstable psychiatric disorders, recent use of investigational drugs or certain CNS medications, pregnant women or those planning to become pregnant during the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Terazosin or placebo for 15 weeks. Terazosin dosage starts at 1mg daily for 6 weeks, increases to 5mg over 3 weeks, and continues for 6 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Terazosin Hydrochloride
Find a Clinic Near You
Who Is Running the Clinical Trial?
Qiang Zhang
Lead Sponsor