Printed from Voxsanity (voxsanity.com.au) — NCT07172815 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting
NCT07172815
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are able to understand and agree to take part in the study (give informed consent).
- People who have someone in their life who can act as a reliable study partner and stay in regular contact with them throughout the trial.
- People who have been clinically diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD).
- People aged 50 years or older.
- People who score between 22 and 28 on a standard memory and thinking test called the Mini-Mental State Examination (MMSE).
- People who score 4 or below on a specific test used to assess whether stroke-related changes to blood vessels in the brain may be contributing to memory problems (confirm with trial site).
- People who are fluent in English and show signs of having had an adequate level of intellectual ability before their current condition developed.
- People who are likely to be able to attend all scheduled visits and complete all required tests throughout the study.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have any medical reasons they cannot take the study drug, tadalafil.
- People who have a significant brain or nervous system condition, other than MCI or Alzheimer's Disease, that may affect thinking and memory.
- People whose brain scan (MRI or CT) shows clear evidence that blood vessel disease in the brain is causing their symptoms.
- People who currently have a significant mental health condition.
- People who currently have a significant physical health condition that is likely to get worse during the study or put them at risk.
- People who have taken part in another clinical trial within the last 3 months.
- People with a history of epilepsy, where seizures or their treatment may have contributed to memory or thinking problems.
- People who have had a serious type of heart attack (ST Elevation Myocardial Infarction) within the last year.
- People who have had cancer in the last 5 years, except for certain localised skin cancers.
- People who have another significant abnormality found during a physical, neurological, or laboratory examination that could affect the study or put them at risk.
- People who have had a problem with alcohol or drug dependence or misuse within the last 2 years.
- People who are currently taking narcotic (opioid-type) medications that could affect thinking or memory.
- People who have previously taken part in a study involving monoclonal antibody treatments, unless it is confirmed that they were receiving a placebo (inactive treatment) in that study.
- Women who are of childbearing potential.
- People who have any medical reasons they cannot have an MRI scan, including those who cannot receive contrast dye used during scanning — for example, people with serious kidney problems (kidney filtration rate below 30 ml/minute) or a known allergy to a type of MRI contrast agent called gadolinium.
- People who have a known sensitivity or allergy to a class of medications called PDE-5 inhibitors.
- People who are currently taking nitrate medications (confirm with trial site for the full list of nitrate medications).
- People with severe heart disease.
- People who have unstable chest pain (angina) at rest or during exercise, or who have diagnosed coronary artery disease causing symptoms.
- People who have had moderate to severe heart failure (classified as New York Heart Association Class 2 or above) within the last 6 months.
- People who have uncontrolled irregular heartbeat, low blood pressure (below 90/50 mmHg), or uncontrolled high blood pressure.
- People who have had a stroke within the last 6 months.
- People who have a condition called pericardial constriction, where the sac around the heart becomes stiff (confirm with trial site).
- People who have life-threatening heart rhythm problems.
- People with severely reduced kidney function (as measured by a specific kidney filtration test falling below a certain threshold), people on dialysis, or people with severe liver disease or liver failure.
- People who have any other reason they cannot take tadalafil, as listed in the medication's official prescribing information.
- People who are currently taking any of the following: other PDE-5 inhibitor medications (apart from tadalafil), other investigational (experimental) drugs, certain medications that strongly affect how the body processes tadalafil (confirm with trial site for the full list), any anti-amyloid or anti-tau therapies, any other experimental treatments for Alzheimer's Disease, or any other therapy that the study doctor judges may affect Alzheimer's Disease.
- For people who agree to an optional spinal fluid (lumbar puncture) procedure only: people who have certain conditions that make a lumbar puncture unsafe, including raised pressure in the skull, a skin infection at the puncture site, a suspected infection near the spine, or certain bleeding or clotting disorders (confirm with trial site for full details).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 August 2028
Primary endpoints
To assess the safety and tolerability of long-term (1 year) tadalafil treatment in MCI and early AD patients.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.