Terazosin for Lewy Body Dementia
(TZ-DLB Trial)

Recruiting in Palo Alto (17 mi)

Overseen byNandakumar Narayanan, MD, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Qiang Zhang

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.

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.

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Participant Groups

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.

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.