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

40 Participants Needed

Trial Summary

What is the purpose of this 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. The goal is to see if the medication helps the body make and use energy better, which could help these patients. The results will guide future studies on this and similar medications.

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.

How does the drug Terazosin Hydrochloride differ from other drugs for Lewy Body Dementia?

Terazosin Hydrochloride is unique because it is primarily used to treat high blood pressure and benign prostatic hyperplasia (enlarged prostate), and its use in Lewy Body Dementia is being explored for its potential to address symptoms differently than existing treatments, which mainly focus on cognitive and motor symptoms without modifying the disease. ^{1 2 3 4 5}

Research Team

Nandakumar Narayanan, MD, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment Efficacy and Acceptabilityof Pharmacotherapies for Dementia with Lewy Bodies: A Systematic Review and Network Meta-Analysis. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Using Clinical Scales and Digital Measures to Explore Falls in Patients with Lewy Body Dementia. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacological Management of Dementia with Lewy Bodies. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. [2022]