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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the control group will receive placebo for 15 weeks.
University of Iowa
Iowa City, Iowa, United States
Incidence of intervention-related adverse events between treatment arms
All patient-reported adverse events will be compared.
Time frame: 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.
Time frame: 15 weeks
Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy
Brain \[ATP\] as measured by 31P-Magnetic Resonance Spectroscopy
Time frame: at baseline, 6 weeks and 15 weeks
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
Time frame: at baseline, 6 weeks and 15 weeks
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
Time frame: at baseline, 6 weeks and 15 weeks
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
Time frame: at baseline, 6 weeks and 15 weeks
Montreal Cognitive Assessment
Montreal Cognitive Assessment
Time frame: at baseline, 6 weeks and 15 weeks
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The Clinician Interview-Based Impression of Change, plus carer interview (CIBIC-Plus)
CIBIC-Plus will be evaluated at baseline and at 12 weeks
Time frame: at baseline, 6 weeks and 15 weeks
Neuropsychiatric inventory
NPI will be evaluated at baseline and at 12 weeks
Time frame: at baseline, 6 weeks and 15 weeks
Fluorodeoxyglucose (FDG)-positron emission tomography (PET)
A surrogate for glucose metabolism in the brain
Time frame: at baseline, 6 weeks and 15 weeks
Serum ATP levels
Serum ATP level changes will be compared between the TZ and the placebo arms
Time frame: at baseline, 6 weeks and 15 weeks
Serum TeraZosin levels
Serum Terazosin levels will be analyzed and a correlation between ATP levels and TZ levels will be evaluated
Time frame: at baseline, 6 weeks and 15 weeks