Terazosin And Metabolic Engagement in Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether terazosin affects how the body uses energy in people with early Alzheimer's disease. It is for adults ages 50–80 with mild memory or thinking problems due to Alzheimer's. People will receive either terazosin or a placebo, a treatment with no active drug.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 50–80 years old.
- A study doctor confirms that Alzheimer's disease is the main cause of your memory or thinking problems.
- A brain scan, spinal fluid test, or blood test shows signs of Alzheimer's disease.
- Your Alzheimer's symptoms are mild. Study tests must show a dementia rating of 0.5 or 1 and a memory score of at least 0.5.
- If you take an acetylcholinesterase inhibitor or memantine for Alzheimer's, your dose has stayed the same for at least 4 weeks.
Who can't join
- You cannot give written consent, or agree with consent from a legal representative when needed. You cannot have an MRI scan or complete study visits, or you recently joined another treatment study or received an experimental drug.
- You have another cause of thinking problems, a serious past brain injury, a stroke or mini-stroke within 12 months, major brain blood vessel damage, seizures needing medicine, or an untreated cause of thinking problems that could be corrected.
- You have a mental health condition that could affect safety or testing, depression or anxiety scores above study limits, certain suicidal thoughts within 12 months, suicidal behavior within 2 years, or an alcohol or drug use disorder within 2 years.
- Your blood pressure drops too much when standing, your seated blood pressure is below 110/60, or you have certain serious heart or blood pressure control problems. Fainting, near-fainting, or 2 or more falls within 12 months also rule you out.
- You use certain medicines, including alpha blockers such as terazosin or tamsulosin, or medicines such as sildenafil or tadalafil. Recent changes to medicines that affect the brain, or an allergy to terazosin or related drugs, also rule you out.
- You receive, plan to receive, are being checked for, or received within 24 months an antibody treatment that targets amyloid, a protein linked to Alzheimer's. Examples include lecanemab and donanemab.
- You have an unstable health condition, certain abnormal liver tests, serious liver or kidney disease, or planned surgery inside the eye. Active cancer or cancer treatment within 2 years also rules you out, except for certain skin and early cervical cancers.
- You are pregnant, breastfeeding, or plan to become pregnant during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
INCLUSION CRITERIA: 1. Male or female, aged 50-80 years (inclusive) at the time of consent. 2. 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. 3. 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. 4. 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. 5. Early symptomatic AD - that is, mild cognitive impairment due to AD or mild AD dementia - as evidenced by a global Clinical Dementia Rating (CDR) score of 0.5 or 1.0 at screening, with a Memory box score ≥ 0.5. EXCLUSION CRITERIA: A participant meeting any of the following at screening is not eligible: Consent and study conduct 1. 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. 2. Receipt of an investigational agent, or participation in an interventional trial, within 30 days or 5 half-lives (whichever is longer) prior to screening. 3. Contraindication to MRI or otherwise unable to undergo MRI (non-compatible implanted device, retained ferromagnetic material, severe claustrophobia, body habitus exceeding scanner limits). 4. Any circumstance that, in the investigator's judgment, would prevent the participant from attending scheduled study visits or completing study procedures. Neurological 5. Cognitive impairment attributable to a cause other than AD, including dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease, progressive supranuclear palsy, vascular dementia, normal pressure hydrocephalus, intracranial mass, or chronic subdural hematoma. 6. History of traumatic brain injury with loss of consciousness \> 30 minutes, post-traumatic amnesia \> 24 hours, or resulting in persistent cognitive or neurological deficit. 7. Stroke or TIA within 12 months prior to screening, or MRI evidence of significant cerebrovascular disease (territorial infarct, more than one lacunar infarct in a strategic location, or confluent white-matter hyperintensity \[Fazekas grade 3\]). 8. Seizure disorder requiring ongoing antiepileptic therapy. 9. Untreated vitamin B12 deficiency, untreated hypothyroidism, or another unresolved reversible contributor to cognitive impairment. Psychiatric 10. Major depressive disorder, bipolar affective disorder, schizophrenia or other psychotic disorder, post-traumatic stress disorder, or another psychiatric condition of sufficient severity to increase adverse event risk or confound neurological and cognitive assessment, in the opinion of the site principal investigator. 11. Beck Depression Inventory-II score \> 21 at screening. 12. Beck Anxiety Inventory score \> 22 at screening. 13. Suicidal ideation within 12 months prior to baseline, as evidenced by a "yes" response to item 4 or 5 of the ideation subscale of the Columbia-Suicide Severity Rating Scale, or any suicidal behavior within 2 years prior to baseline. 14. Alcohol or substance use disorder (DSM-5 criteria) within 2 years prior to screening. Cardiovascular and hemodynamic 15. Orthostatic hypotension, defined as a fall of ≥ 20 mmHg systolic or ≥ 10 mmHg diastolic within 3 minutes of standing from supine, with or without symptoms. 16. Seated systolic blood pressure \< 110 mmHg or diastolic \< 60 mmHg at screening. 17. History of syncope or near-syncope, or ≥ 2 falls, within 12 months prior to screening. 18. Clinically significant cardiovascular disease: myocardial infarction or unstable angina within 6 months, NYHA class III-IV heart failure, hemodynamically significant aortic or mitral stenosis, or uncontrolled arrhythmia. 19. Known autonomic failure or neurogenic orthostatic hypotension. Concomitant medications 20. Current use of any α1-adrenergic antagonist (terazosin, doxazosin, prazosin, alfuzosin, tamsulosin, silodosin), or use within 4 weeks prior to randomization. 21. Current use of a phosphodiesterase-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil), including tadalafil prescribed for benign prostatic hyperplasia or pulmonary hypertension. 22. Known hypersensitivity to terazosin or other quinazoline derivatives. 23. Current treatment with - or planned initiation of, or receipt within 24 months prior to screening of - an anti-amyloid monoclonal antibody (aducanumab, lecanemab, donanemab, or any other approved or investigational agent of this class), or active evaluation for such treatment. 24. Initiation of, or change in dose of, any CNS-active medication (benzodiazepine, antidepressant, antipsychotic, hypnotic, or anticonvulsant) within 30 days prior to baseline. General medical and laboratory 25. Acute or unstable medical, psychiatric, or orthopedic condition that in the investigator's judgment would confound assessment or compromise safety. Stable, adequately controlled chronic conditions common to this age group - including hypertension, diabetes mellitus, hyperlipidemia, and osteoarthritis - are permitted provided the treatment regimen has been unchanged for ≥ 30 days. 26. Hepatic impairment: ALT or AST \> 3 × ULN, total bilirubin \> 1.5 × ULN, or known cirrhosis (Child-Pugh class B or C). 27. eGFR \< 30 mL/min/1.73 m². 28. Cataract or other intraocular surgery planned during the treatment period. 29. Active malignancy, or treatment for malignancy within 2 years, excluding non-melanoma skin cancer and in-situ cervical carcinoma. Reproductive 30. Pregnancy, breastfeeding, or intention to become pregnant during the study period.
Study sites (1)
IA
- University of Iowa · Iowa City, IA 52242Qiang Zhang, MD · Study contact · 4154251369 · qiang-zhang@uiowa.eduNandakumar Narayanan, MD PhD · Study contact · 3193561616 · nandakumar-narayanan@uiowa.eduQiang Zhang, MD · Principal investigatorMore trials in Iowa City