Terazosin for Lewy Body Dementia

(TZ-DLB Trial)

Overseen By Jordan Schultz, Pharm D

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Qiang Zhang

Must be taking: AChEI, Memantine

Must not be taking: Doxazosin, Alfuzosin

Disqualifiers: Orthostatic hypotension, Major depression, others

Compensation: Varies

Number of Visits: 2

Duration: 15 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 3 6 7 8}

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

I have been diagnosed with dementia with Lewy Bodies.

I have been on a stable Alzheimer's medication regimen for at least 4 weeks.

My mental function test score is 18 or higher.

Exclusion Criteria

Presence of other known medical comorbidities that in the investigator's opinion would compromise participation in the study

I am currently taking medication for prostate issues or high blood pressure.

You have had a serious head injury or suffer from post-traumatic stress disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

15 weeks

Visits at baseline, 2 weeks, 6 weeks, 12 weeks, and 15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Terazosin Hydrochloride

Trial Overview

The TZ-DLB trial is testing the tolerability of terazosin hydrochloride compared to a placebo in treating dementia with Lewy bodies. Participants will be randomly assigned in a ratio of 3:2 to either receive terazosin or placebo in this double-blind study where neither they nor the researchers know who gets which treatment.

How Is the Trial Designed?

Group I: Terazosin Arm Experimental Treatment 1 Intervention

Participants 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.

Group II: Placebo Control Arm Placebo Group 1 Intervention

Participants 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.

Who Is Running the Clinical Trial?

Qiang Zhang

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Currently, there are no FDA-approved drugs specifically for treating dementia with Lewy bodies (DLB), and only a few options for Parkinson's disease dementia (PDD), with cholinesterase inhibitors like rivastigmine showing benefits for cognitive symptoms.

Ongoing clinical trials, primarily in phase I and II, are exploring new treatments aimed at modifying the disease rather than just alleviating symptoms, with early results for neflamapimod appearing promising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. MacDonald, S., Shah, AS., Tousi, B.[2022]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04760860

Terazosin for Dementia With Lewy Bodies (TZ-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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38896813/

Association of Terazosin, Doxazosin, or Alfuzosin Use and ...

This study provides Class III evidence that Tz/Dz/Az use reduces the rate of developing DLB in adult men.

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withpower.com

withpower.com/trial/phase-2-dementia-9-2021-d48a8

Terazosin for Lewy Body Dementia (TZ-DLB Trial)

This trial is testing if a medication called terazosin can be tolerated by people with a specific type of dementia called dementia with Lewy bodies.

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cndlifesciences.com

cndlifesciences.com/prostate-drugs-reduce-risk-of-dementia-with-lewy-bodies/

Prostate Medication Reduces the Risk of dementia with ...

Combination of terazosin, doxazosin, and alfuzosin (Tz/Dz/Az), used for the treatment of BPH, reduces the risk of dementia with Lewy bodies.

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neurologyadvisor.com

neurologyadvisor.com/news/dementia-with-lewy-bodies-risk-men-terazosin-doxazosin-alfuzoin/

Dementia With Lewy Bodies Risk in Men Tied to Terazosin ...

Compared with men taking other medications, men taking terazosin, doxazosin, or alfuzosin have a lower risk for dementia with Lewy bodies.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11226317/

Association of Terazosin, Doxazosin, or Alfuzosin Use and ...

This study provides Class III evidence that Tz/Dz/Az use reduces the rate of developing DLB in adult men. Introduction. Dementia with Lewy ...

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medicalnewstoday.com

medicalnewstoday.com/articles/prostate-drugs-like-terazosin-may-help-lower-dementia-with-lewy-bodies-risk

Dementia with Lewy bodies: Can some prostate drugs help ...

Prostate drugs like terazosin may help lower dementia with Lewy bodies risk · Dementia with Lewy bodies is the second most common ...

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lbda.org

lbda.org/eye-on-prevention-clues-from-prostate-therapy/

Eye on Prevention: Clues from Prostate Therapy

According to new research from the University of Iowa, medications used for prostate enlargement may provide clues to future strategies to prevent dementia ...