Actively Recruiting
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
Led by AC Immune SA · Updated on 2025-12-15
176
Participants Needed
19
Research Sites
205 weeks
Total Duration
On this page
Sponsors
A
AC Immune SA
Lead Sponsor
W
Worldwide Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 85 years at screening for prodromal Alzheimer's disease group
- Diagnosis of prodromal Alzheimer's disease meeting NIA-AA criteria
- PET scan at screening showing amyloid pathology
- Clinical Dementia Rating (CDR) Global Score of 0.5
- Either no Alzheimer's treatment or stable dose of acetylcholinesterase inhibitors and/or memantine for at least 2 months before baseline
- Age 35 to 50 years at screening for Down syndrome group (ages 35 to 39 may be considered with evidence of amyloid pathology)
- Male or female with cytogenetic diagnosis of trisomy 21 or complete unbalanced translocation of chromosome 21
- PET scan at screening showing amyloid pathology
- Mild to moderate intellectual disability by DSM-5 criteria
- Have a study partner with direct and regular contact (at least 10 hours per week) able to provide reliable information about the participant
You will not qualify if you...
- Unstable or clinically significant medical conditions that could affect safety or study evaluation
- Drug or alcohol abuse or dependence within past 5 years
- History or presence of uncontrolled seizures (must have been seizure-free for 2 years if history present)
- Psychiatric or neurologic disorders unrelated to Alzheimer's disease
- History of meningitis, meningoencephalitis, moderate or severe traumatic brain injury
- Inflammatory, immunological, or autoimmune disorders
- Severe allergic reactions including to vaccines, foods, or medications
- Significant suicide risk as defined by C-SSRS
- MRI findings showing cerebral edema, hemorrhages, multiple microhemorrhages, or other significant brain pathology
- Clinically significant abnormal blood counts, liver or biochemical tests
- Positive tests for HIV, active hepatitis B or C, or active syphilis
- Positive antibody titers related to immunological or autoimmune disorders at screening
- Contraindications to MRI or PET scans
- Contraindications to lumbar puncture (optional for Down syndrome participants)
- Prior treatment with ACI-24 or active immunotherapy for Alzheimer's disease unless only placebo received
- Recent use of passive immunotherapy for Alzheimer's disease
- Ongoing treatment with approved anti-amyloid passive immunotherapy
- Use of acetylcholinesterase inhibitors or glutamatergic drugs not stable for at least 2 months
- Vaccination within 4 weeks before randomization
- Untreated or unstable hypothyroidism
- Use of certain anticoagulants or antiplatelet drugs (except low dose aspirin) if undergoing lumbar puncture
- Use of some antidepressants, antipsychotics, GABA agonists, or stimulants except stable doses of some allowed
- Chronic opioid use except short-term use for acute conditions
- Current or recent use of immunosuppressant or immunomodulating drugs or steroids
- Additional Down syndrome exclusions at randomization: diagnosis of Alzheimer's dementia, DSQIID score over 20, or IQ below 40 (KBIT-2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Indiana University / IU Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Kansas Medical Center Research Institute
Fairway, Kansas, United States, 66205-2513
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
The Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
6
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2103
Actively Recruiting
7
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
8
Fundació ACE, Institut Català de Neurociències Aplicades
Barcelona, Spain
Actively Recruiting
9
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
10
Hospital Universitario Virgen De Las Nieves
Granada, Spain
Withdrawn
11
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
12
Hospital Universitario de la Princesa
Madrid, Spain
Actively Recruiting
13
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Actively Recruiting
14
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Actively Recruiting
15
Cambridge and Peterborough NHS Foundation Trust - Windsor Research Units
Cambridge, United Kingdom
Actively Recruiting
16
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
17
Re:Cognition Health Limited
London, United Kingdom
Actively Recruiting
18
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital
London, United Kingdom
Actively Recruiting
19
Oxford Health NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
Research Team
O
Olivier Sol, MD
CONTACT
B
Benedicte Le
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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