Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial enrolled 45 adults who had been diagnosed with Mild Cognitive Impairment (MCI) — a condition involving noticeable memory or thinking difficulties that are not yet severe enough to be called dementia. Thirty-six participants completed the study, while nine did not finish. The trial used a brain scanning technique called a PET scan with a tracer called florbetaben, which is designed to detect a protein called beta-amyloid that can build up in the brain. The aim was to see whether the amount of beta-amyloid detected on these scans at the start of the study, and at 12 and 24 months, was different between participants who later went on to be diagnosed with Alzheimer's Disease and those who did not. The reported data shows that participants who eventually progressed to Alzheimer's Disease had higher average beta-amyloid scan readings (called SUVRs — simply a number representing how much of the tracer was detected) than those who did not progress, at all three time points. For those who did not progress to Alzheimer's, the reported average SUVR was around 1.43 at all three scans. For those who did progress, the reported averages were 1.73 at the start, 1.74 at 12 months, and 1.80 at 24 months. Using a cut-off score of 1.4 to label a scan as "abnormal," the reported data shows that the large majority of participants who later progressed to Alzheimer's had abnormal scans, while a sizeable portion of those who did not progress had normal scans. The reported data also shows figures for how well the scan results lined up with eventual Alzheimer's diagnoses. For example, at the 12-month scan, the reported sensitivity (the proportion of people who later developed Alzheimer's who also had an abnormal scan) was 100% at the 45-minute imaging window, and specificity (the proportion of people who did not develop Alzheimer's who had a normal scan) was around 67%. These figures varied depending on the time point and how long after the injection the scan was taken. Some additional detail on predictive values was not broken down further in the reported data beyond what is described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 33773598) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Alzheimer's Disease Trial, Completed
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
- You have been found to have mild memory or thinking problems on formal tests, but do not have dementia or major difficulties with daily activities.
- You do not have any serious medical or neurological conditions that could be causing your memory or thinking problems, or that might stop you from being followed up over two years.
- You are able to read, understand, and sign a consent form agreeing to take part.
- You are 60 years of age or older.
- You have had at least 7 years of formal education.
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.
- You scored below 24 on a standard memory and thinking test called the Mini Mental State Examination (MMSE) at the start of the trial.
- You scored above 0.5 on a standard scale used to measure dementia severity (called the Clinical Dementia Rating, or CDR) at the start of the trial (confirm with trial site).
- You regularly take certain medications that could negatively affect memory or thinking, such as some types of antidepressants, antipsychotics, or high doses of sleeping pills or anti-anxiety medication.
- You currently have or have previously had cancer.
- You have had a serious head injury, brain surgery, or bleeding in the brain that caused lasting brain damage.
- You have a history of serious depression, schizophrenia, or a related mental health condition.
- You are unable to have an MRI scan for any reason (for example, if you have a metal implant).
- You have signs, symptoms, or scan results suggesting a neurological condition other than mild memory problems or mild depression.
- You have had a severe allergic reaction in the past, or are considered to be at high risk of a serious allergic reaction to medications.
- You have taken part in another clinical drug trial in the 14 days before joining this study.
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.
Trial contact details on record
Principal Investigator: Bayer Study Director, Bayer
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 1 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
Other options
Data last synced from ClinicalTrials.gov: 6 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.