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Could a Viagra-Like drug slow Alzheimer's? new trial aims to find out

NCT ID NCT07172815

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether tadalafil, a drug typically used for erectile dysfunction, is safe and can help people with early Alzheimer's or mild cognitive impairment. Over one year, 244 participants will take either tadalafil or a placebo. Researchers will check for side effects and measure changes in memory and thinking skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tadalafil (a drug used for erectile dysfunction, repurposed here)
What this could lead to
If it works, this could point toward a new way to slow memory loss in early Alzheimer's by improving blood flow in the brain.
What could go wrong
This is a mid-stage trial with only 244 people, so results may not apply to everyone. Tadalafil can cause side effects like headache or low blood pressure, and it's not yet proven to help Alzheimer's.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Capable of giving and capacity to give informed consent. 2. An individual who can act as a reliable study partner with regular contact. 3. Participants must meet the clinical criteria of MCI or AD. 4. Age from 50 years. 5. Mini-Mental State Examination (MMSE) score of 22-28. 6. Rosen Modified Hachinski Ischemic score ≤4. 7. Fluency in English and evidence of adequate premorbid intellectual functioning 8. Likely to be able to participate in all scheduled evaluations and complete all required tests. Exclusion Criteria: 1. Any contraindications to the use of tadalafil. 2. Significant neurological disease other than MCI due to AD that may affect cognition. 3. MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease. 4. Current presence of a clinically significant major psychiatric disorder. 5. Current clinically significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study. 6. Any previous enrolment in clinical trials within the last 3 months. 7. History of epilepsy, where seizures or treatment could have contributed to cognitive impairment. 8. ST Elevation Myocardial infarction within the last 1 year. 9. History of cancer within the last 5 years, except localised skin cancer. 10. Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the patient. 11. History of alcohol or drug dependence or abuse within the last 2 years. 12. Current use of narcotic medications which could affect cognition. 13. Patients who have been involved in a monoclonal antibody study are excluded unless it is known that they were receiving placebo in that trial. 14. Women of childbearing potential. 15. Any contraindications to MRI scanning, including contraindications for the use of contrast agents, such as renal failure with the estimated glomerular filtration rate of less than 30 ml/minute or known allergy to gadolinium-based contrast agents. 16. Hypersensitivity to PDE-5 inhibitors. 17. Patients who are taking nitrates (see detailed list of nitrate medications in section 7.5). 18. Severe cardiac diseases. 19. Patients with unstable angina or angina occurring during exercise or patients with symptomatic coronary artery disease. 20. Patients with New York Heart Association Class 2 or greater heart failure in the last 6 months. 21. Patients with uncontrolled arrhythmias, hypotension (\< 90/50 mmHg), or uncontrolled hypertension. 22. Patients with a stroke within the last 6 months. 23. Patients with pericardial constriction. 24. Patients with life-threatening arrhythmias. 25. Patients with severe renal impairment, defined by eGFR \<30 mL/min/1.73 m² or the need for dialysis, and severe hepatic Impairment or any evidence of hepatic failure. 26. Any other contraindication listed in SmPC. 27. Patients who take one or more of the following medications: PDE-5 inhibitors other than tadalafil, any other investigational drugs other than tadalafil, potent inhibitors of CYP3A4 (see detailed list of drugs and consumables in section 7.5), any anti-amyloid or anti-tau therapies, any other investigational therapies for Alzheimer's disease, and any therapy that may affect Alzheimer's disease, as per the judgement of the Investigator. 28. \[Only applicable for those agreeing to undertake an optional lumbar puncture\] Any contraindications of lumbar puncture, including raised intracranial pressure (ICP) with suspected mass effect, skin infections at the puncture site, suspected spinal epidural abscesses, and cellulitis. Individuals with bleeding disorders that may increase the risk of bleeding (e.g. known bleeding diathesis, anticoagulant therapy, thrombocytopenia, abnormal coagulation parameters like prolonged Prothrombin Time (PT), prolonged activated Partial Thromboplastin Time (aPTT), and abnormal International Normalized Ratio (INR) will be excluded from having lumbar puncture.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.