Terazosin for Dementia With Lewy Bodies

NCT04760860 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 202101470
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The TZ-DLB trial will be a 3:2 (active:placebo) randomized, double-blind, placebo-controlled Pilot trial to evaluate the tolerability of terazosin for the treatment of dementia with Lewy bodies.

Conditions

Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (3)

• Incidence of intervention-related adverse events between treatment arms

  All patient-reported adverse events will be compared.

  15 weeks

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

  The number of participants in each group who drop out of the study for any reason will be compared.

  15 weeks

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

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

  at baseline, 6 weeks and 15 weeks

Secondary Outcomes (9)

• To assess the mean change in systolic and diastolic blood pressures

  at baseline, 6 weeks and 15 weeks

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

  at baseline, 6 weeks and 15 weeks

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

  at baseline, 6 weeks and 15 weeks

• Montreal Cognitive Assessment

  at baseline, 6 weeks and 15 weeks

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

  at baseline, 6 weeks and 15 weeks

Study Arms (2)

Placebo Control Arm

PLACEBO COMPARATOR

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.

Other: Placebo

Terazosin Arm

EXPERIMENTAL

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.

Drug: Terazosin Hydrochloride

Interventions

Terazosin Hydrochloride DRUG

In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the Terazosin group will receive Terazosin hydrochloride treatment 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.

Also known as: Terazosin, Hytrin

Terazosin Arm

Placebo OTHER

In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the control group will receive placebo for 15 weeks.

Placebo Control Arm

Eligibility Criteria

• Age: 0 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qiang Zhang: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52252, United States

Location

Related Publications (2)

• Cai R, Zhang Y, Simmering JE, Schultz JL, Li Y, Fernandez-Carasa I, Consiglio A, Raya A, Polgreen PM, Narayanan NS, Yuan Y, Chen Z, Su W, Han Y, Zhao C, Gao L, Ji X, Welsh MJ, Liu L. Enhancing glycolysis attenuates Parkinson's disease progression in models and clinical databases. J Clin Invest. 2019 Oct 1;129(10):4539-4549. doi: 10.1172/JCI129987.

  PMID: 31524631 BACKGROUND

• Simmering JE, Welsh MJ, Liu L, Narayanan NS, Pottegard A. Association of Glycolysis-Enhancing alpha-1 Blockers With Risk of Developing Parkinson Disease. JAMA Neurol. 2021 Apr 1;78(4):407-413. doi: 10.1001/jamaneurol.2020.5157.

  PMID: 33523098 BACKGROUND

MeSH Terms

Conditions

Lewy Body Disease

Interventions

Terazosin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nandakumar Narayanan, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

qiang zhang, MD

CONTACT

4154251369; qiang-zhang@uiowa.edu

Jordan Schultz, Pharm D

CONTACT

jordan-schultz@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate of Neurology

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One year after completion of this study
• Access Criteria: Qualified researchers may contact the PI of this study with reasonable requests for data to be shared. Inquiries must include what hypothesis the researcher intends to test using the shared data.

Locations

US (1)