Terazosin for Dementia With Lewy Bodies (TZ-DLB)
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|ClinicalTrials.gov Identifier: NCT04760860|
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : March 3, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Dementia With Lewy Bodies||Drug: Terazosin Hydrochloride Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 2021|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2023|
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.
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
- Incidence of intervention-related adverse events between treatment arms [ Time Frame: 15 weeks ]All patient-reported adverse events will be compared.
- 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.
- 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
- 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
- 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
- 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
- Montreal Cognitive Assessment [ Time Frame: at baseline, 6 weeks and 15 weeks ]Montreal Cognitive Assessment
- 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
- Neuropsychiatric inventory [ Time Frame: at baseline, 6 weeks and 15 weeks ]NPI will be evaluated at baseline and at 12 weeks
- Fluorodeoxyglucose (FDG)-positron emission tomography (PET) [ Time Frame: at baseline, 6 weeks and 15 weeks ]A surrogate for glucose metabolism in the brain
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||0 Years to 90 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|Contact: qiang zhang, MDemail@example.com|
|Contact: Jordan Schultz, Pharm Dfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52252|
|Contact: qiang zhang, MD email@example.com|
|Contact: Jordan Schultz, PharmD firstname.lastname@example.org|
|Principal Investigator: Nandakumar Narayanan, MD, PhD|
|Principal Investigator:||Nandakumar Narayanan, MD, PhD||University of Iowa|
|Responsible Party:||Qiang Zhang, Associate of Neurology, University of Iowa|
|Other Study ID Numbers:||
|First Posted:||February 18, 2021 Key Record Dates|
|Last Update Posted:||March 3, 2021|
|Last Verified:||February 2021|
|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.|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|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.|
|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|
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