NCT05462106 · AC Immune SA
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
What this study is about
The purpose of this study is to assess the safety, tolerability, immunogenicity and how the drug affects the body effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.
View original scientific description
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.
Interventions
BIOLOGICAL
Placebo (Study Part 1a)
Administration of Placebo in Study Part 1a
BIOLOGICAL
ACI-24.060 at Dose A in Study Part 1a
Administration of Dose A of ACI-24.060 in Study Part 1a
BIOLOGICAL
ACI-24.060 at Dose B in Study Part 1a
Administration of Dose B of ACI-24.060 in Study Part 1a
BIOLOGICAL
ACI-24.060 at Dose C in Study Part 1a
Administration of Dose C of ACI-24.060 in Study Part 1a
BIOLOGICAL
ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
Administration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
BIOLOGICAL
Placebo (Study Part 2)
Administration of Placebo in Study Part 2
BIOLOGICAL
ACI-24.060 at Dose A in Study Part 2
Administration of Dose A of ACI-24.060 in Study Part 2. Dose A will be a dose already tested in Study Part 1a
BIOLOGICAL
ACI-24.060 at Dose B in Study Part 2
Administration of Dose B of ACI-24.060 in Study Part 2
BIOLOGICAL
ACI-24.060 at Dose C in Study Part 2
Administration of Dose C of ACI-24.060 in Study Part 2
BIOLOGICAL
Placebo (Study Part 1b)
Administration of Placebo in Study Part 1b
BIOLOGICAL
ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b
Administration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b
Primary outcome measures
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Time frame: 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)
Time frame: From Screening to Week 100 (Study Part 2)
Number of participants with abnormal MRI results
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Number of participants with abnormal MRI results
Time frame: From Baseline to Week 100 (Study Part 2)
Number of participants with abnormal physical and neurological examination results
Time frame: From 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 results
Time frame: From Baseline to Week 100 (Study Part 2)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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)
Time frame: From Baseline to Week 100 (Study Part 2)
Change from baseline in Anti-Abeta antibody titers in blood
Time frame: From Baseline to Week 100 (Study Part 2)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Study Part 1 1. Age ≥50 and ≤85 years at screening. 2. Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria. 3. PET scan at screening consistent with the presence of amyloid pathology. 4. Clinical Dementia Rating (CDR)-Global Score of 0.5. 5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor (ACHEI) and/or memantine for at least 2 months prior to baseline. Study Part 2 1. Age ≥35 and ≤50 years at screening (subjects with DS with age ≥35 and ≤39 years may be considered on the condition that there is prior evidence of amyloid results compatible with AD pathology at PET-scan and/or in biofluids). 2. Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of the chromosome 21. 3. PET scan at screening consistent with the presence of amyloid pathology. 4. Mild to
Where
- Phoenix, Arizona
- Lady Lake, Florida
- Orlando, Florida
- The Villages, Florida
- Indianapolis, Indiana
- Fairway, Kansas
- Boston, Massachusetts
- St Louis, Missouri
- Matthews, North Carolina
- Cordova, Tennessee
- Nashville, Tennessee
- San Antonio, Texas
Collaborators
Worldwide Clinical Trials
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations