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Terazosin for Dementia With Lewy Bodies (TZ-DLB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760860
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : May 6, 2023
Sponsor:
Information provided by (Responsible Party):
Qiang Zhang, University of Iowa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies Drug: Terazosin Hydrochloride Other: Placebo Phase 1 Phase 2

Detailed Description:
This will be a single center, randomized, double-blind, placebo-controlled, pilot study to assess the tolerability of terazosin (TZ) at 1 and 5 milligrams (MG) daily for patients with DLB. The primary goal of this study is to assess the tolerability of TZ in patients with DLB. This is a pilot study and is not powered to assess efficacy of this medication. Our hope is that this study will guide future studies of this (and similar) medications for the disease modification of DLB. This study is also aimed to learn more about how patients with produce and use energy and if TZ can help to reverse energy deficits that appear in DLB.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: a Randomized, Double Blind, Placebo Controlled Clinical Trial Exploring the Target Engagement and Tolerability of Terazosin Hydrochloride in Patients With Dementia With Lewy Bodies
Estimated Study Start Date : October 2024
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Control Arm
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
In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the control group will receive placebo for 15 weeks.
Experimental: Terazosin Arm
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
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.
Other Name: Terazosin, Hytrin


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of intervention-related adverse events between treatment arms [ Time Frame: 15 weeks ]
    All patient-reported adverse events will be compared.

  2. Frequency of drop-out/discontinuation of study intervention for any reason [ Time Frame: 15 weeks ]
    The number of participants in each group who drop out of the study for any reason will be compared.

  3. Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy


Secondary Outcome Measures :
  1. To assess the mean change in systolic and diastolic blood pressures [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Blood pressure will be evaluated at baseline, 2 weeks, 6 weeks and 12 weeks

  2. Unified Parkinson Disease Rating Scale (UPDRS) part III Motor examination [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Unified Parkinson Disease Rating Scale (UPDRS) part III will be evaluated at baseline, 2 weeks, 6 weeks and 12 weeks

  3. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be evaluated at baseline and 12 weeks

  4. Montreal Cognitive Assessment [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Montreal Cognitive Assessment

  5. The Clinician Interview-Based Impression of Change, plus carer interview (CIBIC-Plus) [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    CIBIC-Plus will be evaluated at baseline and at 12 weeks

  6. Neuropsychiatric inventory [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    NPI will be evaluated at baseline and at 12 weeks

  7. Fluorodeoxyglucose (FDG)-positron emission tomography (PET) [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    A surrogate for glucose metabolism in the brain

  8. Serum ATP levels [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Serum ATP level changes will be compared between the TZ and the placebo arms

  9. Serum TeraZosin levels [ Time Frame: at baseline, 6 weeks and 15 weeks ]
    Serum Terazosin levels will be analyzed and a correlation between ATP levels and TZ levels will be evaluated


Eligibility Criteria
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Ages Eligible for Study:   0 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760860


Contacts
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Contact: qiang zhang, MD 4154251369 qiang-zhang@uiowa.edu
Contact: Jordan Schultz, Pharm D jordan-schultz@uiowa.edu

Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52252
Contact: qiang zhang, MD       qiang-zhang@uiowa.edu   
Contact: Jordan Schultz, PharmD       jordan-schultz@uiowa.edu   
Principal Investigator: Nandakumar Narayanan, MD, PhD         
Sponsors and Collaborators
Qiang Zhang
Investigators
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Principal Investigator: Nandakumar Narayanan, MD, PhD University of Iowa
More Information
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Publications:

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Responsible Party: Qiang Zhang, Associate of Neurology, University of Iowa
ClinicalTrials.gov Identifier: NCT04760860    
Other Study ID Numbers: 202101470
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies
 Prazosin
Terazosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Antihypertensive Agents