Terazosin for Dementia With Lewy Bodies (NCT04760860) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Terazosin for Dementia With Lewy Bodies
United States40 participantsStarted 2027-10
Plain-language 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.
Who can participate
Age range0 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Incidence of intervention-related adverse events between treatment arms
Timeframe: 15 weeks
2
Frequency of drop-out/discontinuation of study intervention for any reason
Timeframe: 15 weeks
3
Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy