Terazosin And Metabolic Engagement in Alzheimer's Disease

ConditionAlzheimer s Disease

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age50-80

SponsorQiang Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 50-80 years (inclusive) at the time of consent.

Diagnosis of Alzheimer's disease meeting the 2011 NIA-AA clinical criteria for mild cognitive impairment due to Alzheimer's disease or probable Alzheimer's disease dementia, with the clinical syndrome attributable to AD as the primary etiology in the judgment of the site investigator.

Alzheimer's disease pathology confirmed by an eligible biomarker: Amyloid PET scan, Cerebrospinal Fluid (CSF) Alzheimer's disease panel or blood Alzheimer's disease panel.

If receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine, the participant must have been on a stable dose for at least 4 weeks before the baseline visit.

Disqualifiers

Unwilling or unable to provide written informed consent or - where decisional capacity is impaired - unwilling or unable to provide assent alongside written consent from a legally authorized representative.

Receipt of an investigational agent, or participation in an interventional trial, within 30 days or 5 half-lives (whichever is longer) prior to screening.

Contraindication to MRI or otherwise unable to undergo MRI (non-compatible implanted device, retained ferromagnetic material, severe claustrophobia, body habitus exceeding scanner limits).

Any circumstance that, in the investigator's judgment, would prevent the participant from attending scheduled study visits or completing study procedures.

Trial design

Design model

Parallel

Treatments tested in this trial

Terazosin (Hytrin)
Drug
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.
Placebo
Other intervention
In this double blind, randomized, placebo controlled phase IIa clinical trial, subjects randomized into the placebo group will receive placebo for 78 weeks.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: TerazosinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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)

Other outcomes

Plasma metabolomics panel

We will perform plasma metabolomics panel with prespecified hypothesis focusing on the 10 metabolites glycolysis pathway and 4 metabolites pentose pathway.

Time frame

At baseline and at 78 weeks (end of study)

Mini-Mental Status Examination (MMSE)

Mini-Mental Status Examination (MMSE) will be evaluated at baseline and 78 weeks (end of study).

Time frame

at baseline and 78 weeks (end of study).

Clinical Dementia Rating - Sum of Boxes (CDR-SOB)

Clinical Dementia Rating - Sum of Boxes (CDR-SOB) will be evaluated at baseline and at 78 weeks (end of study)

Time frame

at baseline and at 78 weeks (end of study)

Sponsors 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

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