ABATE Study: ACI-24.060 for Alzheimer's and Down Syndrome
This study, called ABATE, is testing a treatment called ACI-24.060 for people with early Alzheimer's disease and adults with Down syndrome who do not have dementia. The main goals are to see how safe ACI-24.060 is, how well people tolerate it, and how the body reacts to it. Some participants will receive ACI-24.060 at different doses, while others will receive a placebo (an inactive substance). To join, you must be between 35 and 85 years old. For the Alzheimer's part, you need to have early signs of Alzheimer's and a PET scan showing amyloid plaques (protein clumps in the brain). The study plans to enroll 304 participants.
- Study design
- This is an interventional study with 304 planned participants. It is divided into two main parts, one for Alzheimer's disease and one for Down syndrome.
- What's involved
- Participants will receive either ACI-24.060 or a placebo. Safety will be checked through adverse events and MRI scans, with measurements taken up to 100 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Study Part 1a will be followed for up to 74 weeks, and those in Study Part 1b and Part 2 will be followed for up to 100 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
At a glance
Conditions
Where it's being run
26 sites across 11 statesStudy leadership
- Michael Rafii, MD · PRINCIPAL_INVESTIGATOR · University of Southern California, Alzheimer's Therapeutic Research Institute, 9860 Mesa Rim Rd, San Diego, CA 92121, USA
Who to contact
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What this trial measures
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)From Screening to Week 74 (Study Part 1a) and from Screening to Week 100 (Study Part 1b)
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)From Screening to Week 100 (Study Part 2)
- Number of participants with abnormal MRI resultsFrom Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
- Number of participants with abnormal MRI resultsFrom Baseline to Week 100 (Study Part 2)
- Number of participants with abnormal physical and neurological examination resultsFrom Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
- Number of participants with abnormal physical and neurological examination resultsFrom Baseline to Week 100 (Study Part 2)
- Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
- Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)From Baseline to Week 100 (Study Part 2)
- Change from baseline in Anti-Abeta antibody titers in bloodFrom Baseline to Week 100 (Study Part 2)