Printed from Voxsanity (voxsanity.com.au) — NCT07612150 — 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
NCT07612150
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
- Men, or women who have not had a menstrual period for at least 12 months in a row (not due to medication), aged 60 to 85 years at the time of signing the consent form. Men who are sexually active with a partner who could become pregnant must be willing to follow the trial's contraception requirements and agree not to donate sperm.
- Blood test results showing certain protein levels (called p-Tau217 or p-Tau181) that meet recognised Alzheimer's disease diagnostic guidelines, measured using one of several approved testing methods with specific cut-off values (confirm with trial site).
- People with a clinical diagnosis of either: (a) Mild Cognitive Impairment (MCI) thought to be caused by Alzheimer's disease, with a memory test score of 24–28 and a clinical rating score of 0.5; or (b) mild Alzheimer's disease dementia, with a memory test score of 20–26 and a clinical rating score of 0.5 or 1 — in both cases, supported by blood biomarker results meeting the specific cut-off values listed above.
- A reported history of gradually worsening memory or other thinking difficulties (such as planning, spatial awareness, or language) that began at least 6 months before joining the trial.
- A body mass index (a measure of body weight relative to height) between 17 and 35 at the time of screening.
- People who are currently taking approved Alzheimer's treatments (such as certain memory medications, medium chain triglyceride, Souvenaid, or cognitive supplements) must have been on a stable dose for at least 13 weeks before the study start date; people not currently taking any Alzheimer's treatments may also join, but must agree not to start any such treatments during the trial. All other regular medications must have been at a stable dose for at least 4 weeks before the study start date.
- Having a designated "study partner" — someone who spends 10 or more hours per week with the participant, is willing to provide separate written consent, and is able to attend certain visits in person and provide ongoing information about the participant throughout the trial.
- Ability to provide written informed consent.
- Willingness and ability to follow all aspects of the trial protocol.
- People who previously used curcumin or ginkgo (as a treatment or in another trial) may be eligible after stopping for at least 1 month; people who used other cognitive treatments or participated in other cognitive trials may be eligible after stopping for at least 3 months or 5 half-lives of the treatment, whichever is longer.
- Sufficient reading ability before the illness, and adequate vision, hearing, and physical ability to complete thinking and memory tests, in the investigator's opinion (corrective aids such as glasses or hearing aids are permitted).
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.
- Women who have not yet reached menopause or who are less than 1 year past menopause.
- Anyone who has previously received anti-amyloid therapy.
- People with certain abnormal blood test results at screening, including: liver enzyme levels (ALT or AST) above the normal range, total bilirubin above the normal range (with some exceptions for certain known conditions, at the investigator's discretion), low white blood cell counts (unless that is the person's normal baseline), haemoglobin below 12 g/dL, reduced kidney function below a certain threshold, or total cholesterol of 240 mg/dL or above.
- People who test positive for HIV, Hepatitis B, or Hepatitis C (if confirmed by a specific test or if they have ever received Hepatitis C treatment).
- People with any other neurological condition that may be contributing to memory or thinking problems beyond Alzheimer's disease, such as vascular dementia, Lewy body dementia, frontotemporal dementia, Parkinson's disease, traumatic brain injury, stroke, seizure disorder, or similar conditions.
- A history of mini-strokes (transient ischaemic attacks), stroke, or seizures within 12 months before screening.
- Current diagnosis of certain psychiatric conditions including schizophrenia, other psychotic disorders, major depression, or bipolar disorder.
- A depression screening score of 8 or higher, or any previous suicide attempt.
- People who cannot have an MRI scan, for example due to having a cardiac pacemaker or certain metal implants in the body.
- Brain MRI findings at screening that suggest a dementia diagnosis other than Alzheimer's disease.
- Significant abnormal findings on the brain MRI at screening, such as 4 or more small bleeds, a single bleed larger than 10 mm, signs of swelling or tissue damage, certain types of infarcts or strokes, small vessel disease, or brain tumours (small, non-harmful cysts or coverings of the brain under 1 cm with no pressure effects may not be exclusionary — confirm with trial site).
- A score of 4 or higher on a scale measuring blood vessel-related brain changes, combined with a score of 3 on a scale measuring white matter changes on MRI.
- A known allergy or sensitivity to curcumin or any curcumin-based product.
- Any immune system disease requiring treatment with biologic drugs during the study.
- A bleeding disorder that is not well controlled, including a low platelet count or an abnormal blood clotting result above a certain level.
- Thyroid-stimulating hormone levels outside the normal range, or other thyroid test results considered clinically significant by the investigator (this applies whether or not thyroid medication is being taken).
- Any other significant abnormalities in physical examination, vital signs, blood tests, or heart trace (ECG) at screening or study start that, in the investigator's opinion, need further investigation, pose a safety concern, or could interfere with the study.
- A diagnosis of cancer within the past 3 years (except certain skin cancers or localised prostate cancer); people with a prior cancer history who have been in documented remission for at least 3 years may not be excluded, at the investigator's discretion.
- At screening, any serious suicide risk identified through a standardised assessment tool, including responses indicating certain levels of suicidal thinking within the past 6 months, or a history of hospitalisation or treatment for suicidal behaviour.
- Known or suspected drug or alcohol misuse or dependence within the past 2 years, or a positive urine drug test at screening (with some exceptions for prescribed benzodiazepines or opioids taken for a medical condition, at the investigator's discretion).
- Any unstable or poorly controlled medical condition (for example, heart, lung, digestive, or kidney problems) that could affect safety or interfere with study assessments, in the investigator's opinion.
- Any digestive condition that could affect how the study drug is absorbed, such as gastric bypass surgery or inflammatory bowel disease.
- People who are unable to stop taking supplements containing curcumin or ginkgo for the month before screening.
- People with a known sensitivity to amyloid imaging agents or who cannot have a PET scan will be excluded from the optional PET imaging part of the study; this does not prevent participation in the main study (confirm with trial site).
- A history of serious multiple or severe drug allergies, severe reactions after treatment, anaphylaxis, or a history of multiple drug allergies that, in the investigator's opinion, could interfere with the study.
- A heart electrical interval (QTcF) that is too long on the ECG at screening: above 450 milliseconds for men, above 470 milliseconds for women, or above 480 milliseconds for people with a specific heart conduction condition or an MRI-compatible pacemaker (this test may be repeated once during screening).
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: +886-6-2531571
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Merry Life Biomedical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
30 April 2028
Primary endpoints
Change From Baseline in Clinical Dementia Rating -Sum of Boxes (CDR-SB) Score at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 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.