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 willing and able to give their informed consent to take part in the study.
- People aged between 30 and 90 years old.
- People who have been diagnosed with early Alzheimer's disease, including mild memory and thinking problems (MCI) or mild dementia.
- People whose score on a standard memory and thinking assessment (called the Clinical Dementia Rating scale) is 0.5 or 1.0, indicating very mild to mild impairment.
- People who have had Alzheimer's-related protein buildup (amyloid) confirmed through a spinal fluid test or a brain scan (PET imaging).
- People whose treating doctor has already planned to start them on an anti-amyloid therapy as part of their regular medical care.
- Women who could become pregnant and have been using highly effective contraception for at least one month before the study screening, and who agree to continue using it during the study and for four weeks after it ends.
- Men who could father a child and who agree to use condoms or other effective contraception with their partner during 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 significant brain or neurological conditions other than Alzheimer's disease that could affect thinking or study participation (for example, other types of dementia, serious brain infections, Parkinson's disease, multiple concussions, or epilepsy with recurring seizures).
- People who carry two copies of a gene variant called ApoE4 (known as homozygous ApoE4 genotype) (confirm with trial site).
- People who are currently taking blood-thinning (anticoagulant) medication.
- People whose brain scans show certain blood vessel or bleeding abnormalities, such as more than four small bleeds, one larger bleed, iron deposits on the brain surface, fluid buildup, multiple small strokes, or a significant stroke.
- People whose brain scans show signs of a condition called ARIA, which involves inflammation or abnormalities related to amyloid protein in the brain's blood vessels.
- People who have a history of bleeding disorders that are not well controlled, including those with a very low platelet count or abnormal blood clotting results (and who are not on blood thinners).
- People who are currently receiving a different anti-amyloid therapy other than lecanemab or donanemab (for example, as part of another clinical trial).
- People with serious or unstable medical conditions affecting the heart, liver, kidneys, digestive system, lungs, hormones, nervous system, mental health, immune system, or blood.
- People whose overall health, in their treating doctor's opinion, could interfere with the study results, or who are not expected to live for at least 24 months.
- People who have had cancer in the last 5 years, except for certain low-risk or non-spreading skin cancers, early-stage cervical cancer, slow-progressing prostate cancer, or other cancers considered low risk for returning.
- People who are unable to have MRI or PET scans (for example, due to a non-MRI-safe pacemaker or other implanted device, or severe claustrophobia).
- Women who could become pregnant and are not using adequate contraception, or who are currently pregnant or breastfeeding.
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: Massimo Filippi, IRCCS San Raffaele
Phone: 0226433051
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
Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on a single scan; Predicting time (in months) to amyloid [¹⁸F]Flutemetamol (amyloid) PET negativity on two consecutive scans
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.