Alzheimer's Disease Trial, Not Yet Recruiting
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 have been diagnosed with dementia caused by Alzheimer's disease, according to the 2024 guidelines set by the National Institute on Aging and the Alzheimer's Disease Association.
- People who are male or post-menopausal female, aged between 50 and 90 years old (inclusive), and who have completed at least primary school education.
- People whose score on a standard memory and thinking test (called the MMSE) falls at or below a certain threshold based on their education level, and whose disease severity score (CDR) is greater than 2.0.
- People whose score on a daily living activities scale (ADL Rating Scale) is greater than 0 but no more than 40 points.
- People who have been assessed as being at nutritional risk, with a score of 3 or more on the NRS2002 Nutritional Risk Screening tool at the time of screening and enrolment.
- People who are in generally good overall health, with a functioning level score (ECOG) of 3 or below.
- People who are either not currently receiving any Alzheimer's disease treatment, or who have been on a stable dose of approved Alzheimer's treatments (such as acetylcholinesterase inhibitors, GV-971, or NMDA receptor antagonists) for at least 12 weeks before the start of the trial, with stable results on cognitive assessments; all other non-Alzheimer's medications must also have been at a stable dose for at least 4 weeks before the start of the trial.
- People who have a stable and reliable caregiver, as confirmed by the trial investigator.
- People who are willing to take part voluntarily, have been fully informed about the study, have signed a consent form (or had one signed by an authorised caregiver or guardian where required by local laws), and are willing and able to complete all trial procedures, including providing blood, stool, and urine samples for research analysis.
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 whose dementia is caused by something other than Alzheimer's disease, such as vascular dementia, brain infections (e.g., AIDS or syphilis), Huntington's disease, Parkinson's disease, Lewy body dementia, brain injury, exposure to drugs, alcohol, or carbon monoxide, serious organ-related brain conditions (such as liver, lung, or oxygen-related brain disease), brain tumours or bleeding around the brain, thyroid or adrenal gland disorders, vitamin deficiencies, or any other non-Alzheimer's cause.
- People who have other autoimmune conditions, such as multiple sclerosis, rheumatoid arthritis, lupus, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, polymyositis, or vitiligo.
- People with severely reduced kidney function (creatinine clearance below 30mL/min), severe liver problems (certain liver enzyme levels more than 10 times the normal upper limit, or conditions such as active hepatitis or cirrhosis), a heart attack or heart procedure in the past 6 months, serious heart failure (Grade III–IV), or other serious conditions affecting the nervous system, heart, lungs, blood, hormones, or mental health.
- People who are suspected of having, or who have a history of, alcohol or drug misuse.
- People whose life expectancy is estimated to be 3 months or less.
- People who are pregnant or breastfeeding, or people of childbearing potential (including male participants whose female partners could become pregnant) who plan to become pregnant or are unwilling to use effective contraception from the start of screening until 3 months after stopping the trial treatment.
- People who are known to be allergic to any ingredient in the trial products.
- People who have participated in another drug clinical trial within the 30 days before screening, or who are currently taking part in another clinical trial.
- People who have other serious physical or psychiatric conditions, or significant abnormal laboratory results, that the investigator considers would make participation in this study unsafe or unsuitable.
- People with a clinically severe mental disorder or significant psychiatric symptoms.
- People whose MMSE memory and thinking test score is above 26 points.
- People whose daily living activities (ADL) rating scale score is above 40 points.
- People with abnormally elevated cancer markers in their blood, a history of cancer, or an unclear cancer status (confirm with trial site).
- People who are considered to be at serious risk of suicide.
- People who cannot tolerate or are allergic to the medications used in this study.
- People who have had a clinically significant heart or stroke-related condition requiring treatment within the past 6 months, or a new diagnosis of such a condition within the past 2 months (confirm with trial site for exact timeframe).
- People who have used antibiotics for more than 10 consecutive days in the 12 weeks before the start of the trial, or who are expected to need antibiotics for more than 10 days during the trial.
- People with any other unstable or poorly controlled medical condition — such as heart, breathing, kidney, or digestive problems (for example, stomach cancer, gastric bypass surgery, or ongoing diarrhoea) — that could affect their safety or the reliability of study results.
- People with any other significant abnormality found during physical examination, vital signs, laboratory tests, or heart tracing (ECG) that the investigator believes requires further investigation, could affect safety, or could interfere with the study.
- People with bleeding disorders that are not adequately controlled, including a very low platelet count or abnormal blood clotting results in people not already on blood-thinning medication.
- People whom the investigator considers unsuitable for participation for any other reason.
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.
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: +86057156739127
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Hemoglobin; Albumin; Serum prealbumin; 25-hydroxyvitamin D; Alkaline phosphatase; Parathyroid hormone; Calcitonin; Whole abdominal Computerized tomography (CT) scan; Diagnostic criteria of the 2019 Asian Sarcopenia Working Group
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.