Terazosin for Dementia With Lewy Bodies
ConditionDementia With Lewy Bodies
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age0-90
SponsorQiang Zhang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Terazosin Hydrochloride
DrugIn 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.
Placebo
Other interventionIn this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the control group will receive placebo for 15 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Placebo Control ArmPlacebo comparator 1 intervention
Group B: Terazosin ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of intervention-related adverse events between treatment arms
All patient-reported adverse events will be compared.
Time frame
15 weeks2
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 weeks3
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
Montreal Cognitive Assessment
Montreal Cognitive Assessment
Time frame
at baseline, 6 weeks and 15 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qiang Zhang
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: