The TAME-AD trial will be a randomized, double-blind, placebo-controlled Phase IIa clinical trial to evaluate the metabolic target engagement of terazosin for the treatment of Alzheimer's disease.
This will be a single center, randomized, double-blind, placebo-controlled, Phase IIa study to assess the target engagement of terazosin (TZ) at up to 5 milligrams (MG) daily for patients with Alzheimer's disease. The primary goal of this study is to assess the target engagement 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 medication for the disease modification of Alzheimer's disease. This study is also aimed to learn more about how patients with Alzheimer's disease produce and use energy and if TZ can help to reverse energy deficits that appear in Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
In this double blind, randomized, placebo controlled phase IIa clinical trial, subjects randomized into the Terazosin group will receive Terazosin hydrochloride treatment for 78 weeks. Participants will start at 1mg daily for the first 2 weeks, then the dosage will be increased to 5mg daily over 6 weeks, and continued through the end of the study.
In this double blind, randomized, placebo controlled phase IIa clinical trial, subjects randomized into the placebo group will receive placebo for 78 weeks.
University of Iowa
Iowa City, Iowa, United States
Whole blood ATP level
Whole blood ATP level measured by ATP luciferase Assay.
Time frame: At baseline, 2 weeks (TZ 1mg), 4weeks (2mg), 6 weeks (3mg), 8 weeks (4mg) , 10 weeks (5mg), and 78 weeks (5mg end of study)
Incidence of intervention-related adverse events between treatment arms
All patient-reported adverse events will be compared.
Time frame: At 78 weeks or the end of the study
Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy
Brain \[ATP\] as measured by 31P-Magnetic Resonance Spectroscopy
Time frame: At baseline and at 78 weeks (end of study)
To assess the mean change in systolic and diastolic blood pressures
Blood pressure will be evaluated at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 78 weeks (end of study).
Time frame: at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 78 weeks (end of study).
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) will be evaluated at baseline and 78 weeks (end of study).
Time frame: at baseline and 78 weeks (end of study).
Plasma Terazosin levels
Plasma Terazosin levels will be analyzed and a correlation between whole blood ATP levels and TZ levels will be evaluated
Time frame: At baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 78 weeks (end of study)
Frequency of drop-out/discontinuation of study intervention for any reason
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The number of participants in each group who drop out of the study for any reason will be compared.
Time frame: 78 weeks
Fluorodeoxyglucose (FDG)-positron emission tomography (PET)
A surrogate for glucose metabolism in the brain
Time frame: At baseline and 78 weeks (end of study)