Dementia With Lewy Bodies Clinical Trial
— TZ-DLBOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 2026 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Qiang Zhang |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of intervention-related adverse events between treatment arms | All patient-reported adverse events will be compared. | 15 weeks | |
Primary | 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 | |
Primary | 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 | To assess the mean change in systolic and diastolic blood pressures | Blood pressure will be evaluated at baseline, 2 weeks, 6 weeks and 12 weeks | at baseline, 6 weeks and 15 weeks | |
Secondary | Unified Parkinson Disease Rating Scale (UPDRS) part III Motor examination | Unified Parkinson Disease Rating Scale (UPDRS) part III will be evaluated at baseline, 2 weeks, 6 weeks and 12 weeks | at baseline, 6 weeks and 15 weeks | |
Secondary | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be evaluated at baseline and 12 weeks | at baseline, 6 weeks and 15 weeks | |
Secondary | Montreal Cognitive Assessment | Montreal Cognitive Assessment | at baseline, 6 weeks and 15 weeks | |
Secondary | The Clinician Interview-Based Impression of Change, plus carer interview (CIBIC-Plus) | CIBIC-Plus will be evaluated at baseline and at 12 weeks | at baseline, 6 weeks and 15 weeks | |
Secondary | Neuropsychiatric inventory | NPI will be evaluated at baseline and at 12 weeks | at baseline, 6 weeks and 15 weeks | |
Secondary | Fluorodeoxyglucose (FDG)-positron emission tomography (PET) | A surrogate for glucose metabolism in the brain | at baseline, 6 weeks and 15 weeks | |
Secondary | Serum ATP levels | Serum ATP level changes will be compared between the TZ and the placebo arms | at baseline, 6 weeks and 15 weeks | |
Secondary | Serum TeraZosin levels | Serum Terazosin levels will be analyzed and a correlation between ATP levels and TZ levels will be evaluated | at baseline, 6 weeks and 15 weeks |
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