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Alpha-1 Adrenergic Blocker

Terazosin for Lewy Body Dementia (TZ-DLB Trial)

Phase 1 & 2

Waitlist Available

Led By Nandakumar Narayanan, MD, PhD

Research Sponsored by Qiang Zhang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women with the diagnosis of dementia with Lewy Bodies per 2017 DLB Consortium criteria

Baseline MOCA 18 or above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 6 weeks and 15 weeks

Awards & highlights

TZ-DLB Trial Summary

This trial will test whether terazosin is a tolerable treatment for dementia with Lewy bodies.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from terazosin may include dizziness due to low blood pressure (orthostatic hypotension), fatigue, nasal congestion, headache, and weakness. Since it's being tested against a placebo which has no active ingredients, any side effects would be compared between the two groups.

TZ-DLB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with dementia with Lewy Bodies.

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My mental function test score is 18 or higher.

TZ-DLB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 6 weeks and 15 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 6 weeks and 15 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 6 weeks and 15 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy

Frequency of drop-out/discontinuation of study intervention for any reason

Incidence of intervention-related adverse events between treatment arms

Secondary outcome measures

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

Fluorodeoxyglucose (FDG)-positron emission tomography (PET)

Montreal Cognitive Assessment

+6 more

TZ-DLB Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Terazosin ArmExperimental Treatment1 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 ArmPlacebo Group1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Qiang ZhangLead Sponsor

Nandakumar Narayanan, MD, PhDPrincipal InvestigatorUniversity of Iowa

1 Previous Clinical Trials

13 Total Patients Enrolled

Media Library

Terazosin Hydrochloride (Alpha-1 Adrenergic Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04760860 — Phase 1 & 2

Dementia Research Study Groups: Placebo Control Arm, Terazosin Arm

Dementia Clinical Trial 2023: Terazosin Hydrochloride Highlights & Side Effects. Trial Name: NCT04760860 — Phase 1 & 2

Terazosin Hydrochloride (Alpha-1 Adrenergic Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04760860 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any extant research projects exploring the effects of Terazosin Hydrochloride?

"At this moment in time, there are 3 clinical trials underway investigating the effects of Terazosin Hydrochloride. None of these investigations is currently at Phase 3 and all take place within Los Angeles, California with three distinct sites available for enrolment."

Answered by AI

Who would be an ideal candidate for this clinical investigation?

"Aspirationally, this trial seeks to include 40 patients that suffer from dementia and are within the age bracket of 0-90 years old."

Answered by AI

What tangible outcomes is this clinical trial seeking to achieve?

"This trial is intended to measure the proliferation of adverse events between treatment arms over baseline, 6 weeks, and 15 weeks. Secondary objectives include a comparison of systolic/diastolic blood pressures at baseline, two weeks in length intervals up until 12 weeks as well as an assessment of glucose metabolism via FDG-PET scans and correlational analysis between ATP levels and Terazosin serum concentrations."

Answered by AI

To what extent are patients being administered treatment in this study?

"Unfortunately, no more patients can currently be accepted into this research trial; the study was initially published on October 1st 2021 and last modified on February 26th 2021. If you are pursuing other studies, there's an abundance of options with 402 trials presently accepting people suffering from dementia and 3 clinical trials recruiting for Terazosin Hydrochloride treatments."

Answered by AI

Does this research project accept participants who have not yet reached their sixtieth birthday?

"This investigation is accepting participants aged 0-90 years old."

Answered by AI

Are there any available slots in this clinical experiment?

"This research project is not accepting any new participants at this time. When it was first listed on October 1st 2021, and no changes have been made since February 26th 2021. Should you wish to explore other clinical trials for dementia related topics or Terazosin Hydrochloride there are currently 402 and 3 open studies respectively."

Answered by AI

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All > Dementia With Lewy Bodies