Alzheimer s DiseasePhase 2TAME-ADNCT07796308
Terazosin And Metabolic Engagement in Alzheimer's Disease
A Phase 2 study testing Terazosin (Hytrin) in people with Alzheimer s Disease, run by Qiang Zhang at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- Terazosin (Hytrin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2027to 31 Jul 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- A participant meeting any of the following at screening is not eligible:
- Consent and study conduct
- 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.
Show all 38Show fewer
- Neurological
- 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.
- History of traumatic brain injury with loss of consciousness > 30 minutes, post-traumatic amnesia > 24 hours, or resulting in persistent cognitive or neurological deficit.
- 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]).
- Seizure disorder requiring ongoing antiepileptic therapy.
- Untreated vitamin B12 deficiency, untreated hypothyroidism, or another unresolved reversible contributor to cognitive impairment.
- Psychiatric
- 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.
- Beck Depression Inventory-II score > 21 at screening.
- Beck Anxiety Inventory score > 22 at screening.
- 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.
- Alcohol or substance use disorder (DSM-5 criteria) within 2 years prior to screening.
- Cardiovascular and hemodynamic
- 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.
- Seated systolic blood pressure < 110 mmHg or diastolic < 60 mmHg at screening.
- History of syncope or near-syncope, or ≥ 2 falls, within 12 months prior to screening.
- 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.
- Known autonomic failure or neurogenic orthostatic hypotension.
- Concomitant medications
- Current use of any α1-adrenergic antagonist (terazosin, doxazosin, prazosin, alfuzosin, tamsulosin, silodosin), or use within 4 weeks prior to randomization.
- Current use of a phosphodiesterase-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil), including tadalafil prescribed for benign prostatic hyperplasia or pulmonary hypertension.
- Known hypersensitivity to terazosin or other quinazoline derivatives.
- 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.
- 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
- 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.
- Hepatic impairment: ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN, or known cirrhosis (Child-Pugh class B or C).
- eGFR < 30 mL/min/1.73 m².
- Cataract or other intraocular surgery planned during the treatment period.
- Active malignancy, or treatment for malignancy within 2 years, excluding non-melanoma skin cancer and in-situ cervical carcinoma.
- Reproductive
- Pregnancy, breastfeeding, or intention to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Iowa
Iowa City, Iowa, 52242
Qiang Zhang, MD, 4154251369, qiang-zhang@uiowa.edu
Nandakumar Narayanan, MD PhD, 3193561616, nandakumar-narayanan@uiowa.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Alzheimer s Disease
- Being tested
- Terazosin (Hytrin), Placebo
- Keywords
- Terazosin, Alzheimer's disease, Glycolysis, FDG-PET, MRS, ATP
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
In this double blind, randomized, placebo controlled phase IIa clinical trial, subjects randomized into the placebo group will receive placebo for 78 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants in this arm will receive placebo during the trial for 78 weeks, the placebo will follow the same schedule as the Terazosin group; the placebo capsules will have the same appearance as the Terazosin capsules. Receives: Other: Placebo |
| Terazosin | Experimental | Participants in this arm 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. Receives: Drug: Terazosin (Hytrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole blood ATP level
Whole blood ATP level measured by ATP luciferase Assay.
Measured: 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.
Measured: At 78 weeks or the end of the study
Secondary outcomes (6)
Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy
Brain [ATP] as measured by 31P-Magnetic Resonance Spectroscopy
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
The number of participants in each group who drop out of the study for any reason will be compared.
Measured: 78 weeks
Fluorodeoxyglucose (FDG)-positron emission tomography (PET)
A surrogate for glucose metabolism in the brain
Measured: At baseline and 78 weeks (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Aug 2027 (estimated)
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiang Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiang Zhang, University of Iowa
- Investigators
- Qiang Zhang, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796308
- Sponsor's protocol ID
- 202608376
- Acronym
- TAME-AD
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
Publications
Hart A, Aldridge G, Zhang Q, Narayanan NS, Simmering JE. Association of Terazosin, Doxazosin, or Alfuzosin Use and Risk of Dementia With Lewy Bodies in Men. Neurology. 2024 Jul 23;103(2):e209570. doi: 10.1212/WNL.0000000000209570. Epub 2024 Jun 19.
PubMed 38896813Zhang Q, Schultz JL, Simmering JE, Kirkpatrick BQ, Weber MA, Skuodas S, Hicks T, Pierce G, Laughlin M, George B, Bertolli AX, Larson T, Thangavel R, Oya M, Meyerholz DK, Aldridge G, Fassler J, Narayanan NS. Glycolysis-enhancing alpha1-adrenergic antagonists have therapeutic potential in Alzheimer's disease. Alzheimers Res Ther. 2026 Jul 9. doi: 10.1186/s13195-026-02135-z. Online ahead of print.
PubMed 42426853
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terazosin And Metabolic Engagement in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07796308
- Acronym / sponsor ID
- TAME-AD / 202608376
- Conditions
- Alzheimer s Disease
- Keywords
- Terazosin, Alzheimer's disease, Glycolysis, FDG-PET, MRS, ATP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qiang ZhangUniversity, hospital or other
- Study start
- 1 Aug 2027 (estimated)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive placebo during the trial for 78 weeks, the placebo will follow the same schedule as the Terazosin group; the placebo capsules will have the same appearance as the Terazosin capsules. |
| Terazosin | Experimental | Drug: Terazosin (Hytrin)Participants in this arm 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (38 listed)
- Consent and study conduct
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terazosin (Hytrin)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. | Drug | Terazosin |
| PlaceboIn this double blind, randomized, placebo controlled phase IIa clinical trial, subjects randomized into the placebo group will receive placebo for 78 weeks. | Other | Placebo |
Primary outcome
Whole blood ATP level
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)
Whole blood ATP level measured by ATP luciferase Assay.
Incidence of intervention-related adverse events between treatment arms
Time frame: At 78 weeks or the end of the study
All patient-reported adverse events will be compared.
6 secondary outcomes
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
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)
Time frame: at baseline and 78 weeks (end of study).
Plasma Terazosin levels
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
Time frame: 78 weeks
Fluorodeoxyglucose (FDG)-positron emission tomography (PET)
Time frame: At baseline and 78 weeks (end of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 38896813Hart A, Aldridge G, Zhang Q, Narayanan NS, Simmering JE. Association of Terazosin, Doxazosin, or Alfuzosin Use and Risk of Dementia With Lewy Bodies in Men. Neurology. 2024 Jul 23;103(2):e209570. doi: 10.1212/WNL.0000000000209570. Epub 2024 Jun 19.
- Background: PubMed 42426853Zhang Q, Schultz JL, Simmering JE, Kirkpatrick BQ, Weber MA, Skuodas S, Hicks T, Pierce G, Laughlin M, George B, Bertolli AX, Larson T, Thangavel R, Oya M, Meyerholz DK, Aldridge G, Fassler J, Narayanan NS. Glycolysis-enhancing alpha1-adrenergic antagonists have therapeutic potential in Alzheimer's disease. Alzheimers Res Ther. 2026 Jul 9. doi: 10.1186/s13195-026-02135-z. Online ahead of print.
- Individual participant dataSharing planned: Yes. Upon reasonable request with justification for request from qualified researchers, anonymized data will be shared.
Related trials for Alzheimer s Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruitingObservational study
Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)
Alzheimer s Disease, Mild Cognitive Impairment (MCI)
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
RecruitingPhase 1
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Alzheimer s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Zhang, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terazosin (Hytrin) in people with Alzheimer s Disease, run by Qiang Zhang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiang Zhang, MD (4154251369, qiang-zhang@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole blood ATP level (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07796308, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.