Phase 3 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 are members of a family known to carry the PSEN1 E280A genetic mutation.
- People who agree to undergo genetic testing as part of the trial (including testing for genes such as APOE and PSEN1 E280A, as permitted by local rules).
- People aged 25 to 65 years (male or female).
- People whose thinking and memory are considered normal, based on a standard memory test score — with the passing score depending on the number of years of education completed.
- People who have mild memory problems (mild cognitive impairment with memory-related symptoms), based on a standard word recall test — with the score threshold depending on years of education — and who are still mostly independent in daily activities, in the investigator's judgment.
- People who have been diagnosed with mild Alzheimer's disease dementia, meeting recognised 2011 research criteria for probable Alzheimer's disease, and who score in a specific range on a standard clinical rating scale (CDR Global Score of 0.5 or 1, with a memory box score of at least 0.5).
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 with a significant medical, psychiatric, or neurological condition or disorder that, in the investigator's opinion, could put them at risk or affect how trial results are interpreted.
- People with a history of stroke.
- People with a history of severe brain injury that caused lasting neurological damage or structural changes to the brain (such as a brain bruise from trauma).
- People who currently have bipolar disorder or another significant psychiatric condition, or symptoms such as hallucinations, agitation, or paranoia, that could affect their ability to complete trial assessments.
- People with a history of seizures, with some exceptions for childhood febrile seizures or isolated seizure episodes that were not due to epilepsy, required only short-term treatment, and occurred more than 7 years before the screening visit (confirm with trial site).
- Women who are pregnant or planning to become pregnant during the trial.
- Women who are breastfeeding or planning to breastfeed during the trial.
- People with a known or previous allergic reaction to donanemab, RG6289, or any of the ingredients in RG6289.
- People with a history of or currently active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- People with a history of cancer in the past 5 years, unless the cancer is considered cured, is not being actively treated and is not expected to require treatment in the next 5 years, is prostate cancer or basal cell carcinoma with no significant progression in the past 2 years, is cervical carcinoma in-situ that has been successfully treated, or involves fully removed non-melanoma skin cancers or in-situ melanoma.
- People who have had surgery or been hospitalised in the 4 weeks before screening, or who have surgery or hospitalisation planned during the trial period, if the investigator considers this may affect eligibility.
- People who are unable to have an MRI scan or have a reason why MRI is not safe for them — for example, certain pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal objects in the body or eyes.
- People who have taken any other investigational treatment — including certain anti-amyloid small molecule drugs — within 16 weeks or five half-lives before screening (whichever is longer), unless they can be confirmed to have received placebo in that previous study (confirm with trial site).
- People who participated in an anti-amyloid therapy trial less than 1 year ago.
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.
Contact this trial
Principal Investigator: Robert Alexander, M.D., Banner Alzheimer's Institute
Phone: (602) 839 - 6020
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
Where this trial is recruiting
Primary endpoints
Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint; Part 2: Maintenance of Low Levels of Brain Amyloid as Measured by centiloid (Cl) [F18]Florbetapir-PET Following Combined Intervention of Donanemab and RG6289
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.