Phase 2 study for people with Alzheimer's Disease
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Investigational Site Number : 0360001 | Macquarie Park | NSW | Recruiting |
| Investigational Site Number : 0360004 | Melbourne | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.
* Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \[NIA-AA\] Stage 3) or mild AD dementia (NIA-AA Stage 4).
* Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.
* Have a study partner who must provide separate written informed consent at screening. Study partner should be \>18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.
* The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.
Exclusion Criteria:
* The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).
* The participant has evidence of more than 4 microhemorrhages (\<10 mm in diameter) or superficial siderosis.
* The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4).
* The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.
* The participant is currently receiving anticoagulant therapies.
* The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 22 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.