TZ-DLB

Not yet recruitingPhase 1 / PHASE2

Terazosin for Dementia With Lewy Bodies

a Randomized, Double Blind, Placebo Controlled Clinical Trial Exploring the Target Engagement and Tolerability of Terazosin Hydrochloride in Patients With Dementia With Lewy Bodies

Lead sponsor

Qiang Zhang

Asset

Terazosin Hydrochloride

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Lewy body dementia

Key I/E criteria

•Dementia with Lewy bodies•MoCA ≥4

Primary endpoints

•Intervention-related adverse events between treatment arms•Drop-out/discontinuation of study intervention for any reason•Brain [ATP]

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID202101470

NCT IDNCT04760860

Timeline

Milestones

Study first posted2021-02-18actual

Last update posted2026-03-12actual

Study start2027-10estimated (month precision)

Primary completion2030-10estimated (month precision)

Study completion2030-12estimated (month precision)

Assets

Drug assets

Terazosin Hydrochloride

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age0 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•Baseline MOCA 18 or above. On stable AChEI and/or memantine treatment regimen for ≥4 weeks prior to baseline

Exclusion criteria

•Subjects unwilling or unable to give informed consent

•No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days.

•Orthostatic hypotension defined as symptomatic decrease in BP > 20mmHg systolic or > 10mmHg diastolic on supine to sitting or standing, or a sitting blood pressure of ≤90/60.

•Clinically significant traumatic brain injury or post-traumatic stress disorder

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

•Psychiatric comorbidities including major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neurology assessment in the opinion of the responsible site principal investigator. Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit. Current suicidal ideation within one year prior to the baseline visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit.

•Use of investigational drugs within 30 days before screening

•Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit

•Use of doxazosin, alfuzosin, prazosin, or tamsulosin

•For female participant, pregnancy, or plans for child-bearing during study period

•Participant is restricted from traveling to and from the study site

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Other clinical outcomes

Behavior / neuropsychiatric

Neuroimaging

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

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

Time frame:at baseline, 6 weeks and 15 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Montreal Cognitive Assessment

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric inventory

Time frame:at baseline, 6 weeks and 15 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

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

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Incidence of intervention-related adverse events between treatment arms

Time frame:15 weeks

event count, event

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

To assess the mean change in systolic and diastolic blood pressures

Time frame:at baseline, 6 weeks and 15 weeks

change from baseline, improvement

Secondary/protocol endpoint

The Clinician Interview-Based Impression of Change, plus carer interview (CIBIC-Plus)

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:15 weeks

event count, event

Secondary/protocol endpoint/low confidence

Unified Parkinson Disease Rating Scale (UPDRS) part III Motor examination

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Secondary/protocol endpoint/low confidence

Fluorodeoxyglucose (FDG)-positron emission tomography (PET)

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Secondary/protocol endpoint/low confidence

Serum ATP levels

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Secondary/protocol endpoint/low confidence

Serum TeraZosin levels

Time frame:at baseline, 6 weeks and 15 weeks

descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.