Actively Recruiting
A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Safety and Effects of ACI-24.060 in Prodromal Alzheimer's Disease and Adults With Down Syndrome
Led by AC Immune SA · Updated on 2026-05-29
304
Participants Needed
26
Research Sites
N/A
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
Researchers are evaluating the safety, tolerability, immune response, and pharmacodynamic effects of ACI-24.060 in two groups: people with prodromal Alzheimer's disease and non-demented adults with Down syndrome. This phase 1b/2 study is divided into two parts, with Part 1 focusing on prodromal Alzheimer's disease and Part 2 on adults with Down syndrome. The study involves randomized, placebo-controlled, and double-blind methods to assess this investigational treatment. Participants with prodromal Alzheimer's disease receive either placebo or varying doses of ACI-24.060, including some with an additional adjuvant, over 48 to 74 weeks depending on the dose group. Adults with Down syndrome receive placebo or different doses of ACI-24.060 over 74 weeks, with some doses tested previously in Part 1. The dosing schedules follow predefined time points during these periods. Participants will undergo assessments including monitoring for adverse events, brain MRI scans, physical and neurological exams, and evaluations of suicidal ideation using standardized scales. Blood tests will measure antibody levels against beta-amyloid. These measures will be tracked from baseline through the study periods lasting up to 100 weeks. Safety and immune responses will be closely followed to understand the effects of ACI-24.060 in these populations.
CONDITIONS
Brief 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 with prodromal Alzheimer's disease diagnosed by MCI due to AD criteria
- PET scan confirming amyloid pathology for prodromal AD participants
- Clinical Dementia Rating (CDR) Global Score of 0.5 for prodromal AD
- Stable or no current treatment with acetylcholinesterase inhibitors or memantine for at least 2 months prior for prodromal AD
- Age 35 to 50 years with Down syndrome, with younger subjects 35 to 39 considered if amyloid evidence is present
- Cytogenetic diagnosis of trisomy 21 or complete unbalanced translocation of chromosome 21 for Down syndrome
- PET scan confirming amyloid pathology for Down syndrome participants
- Mild to moderate intellectual disability by DSM-5 criteria for Down syndrome
- Must have a study partner with direct and regular contact of at least 10 hours per week
You will not qualify if you...
- Unstable or clinically significant medical conditions affecting safety or study evaluation
- Substance use disorders (except tobacco) in past 5 years
- History of uncontrolled seizures or seizures within 2 years prior to screening
- Significant psychiatric or neurological disorders unrelated to Alzheimer's disease
- History of meningitis, moderate/severe brain injury, inflammatory neurological disorders, or autoimmune disorders
- History of severe allergic reactions including to vaccines
- Significant suicide risk per Columbia-Suicide Severity Rating Scale
- Abnormal MRI findings such as cerebral edema, multiple microhemorrhages, or lesions
- Clinically significant abnormal blood, liver, or biochemical tests
- Positive tests for HIV, active hepatitis B or C, or active syphilis
- Contraindications to MRI, PET scan, or lumbar puncture
- Prior treatment with ACI-24 or active immunotherapy against Alzheimer's disease unless proven placebo only
- Use of investigational or marketed passive anti-amyloid immunotherapy within 6 months or 5 half-lives
- Ongoing treatment with approved anti-amyloid passive immunotherapy
- Unstable doses or recent changes in acetylcholinesterase inhibitors or glutamatergic drugs
- Vaccination within 4 weeks prior to randomization
- Untreated or unstable hypothyroidism
- Use of anticoagulants or antiplatelets (except low-dose aspirin) when undergoing lumbar puncture
- Use of certain psychiatric medications unless stable and approved by investigators
- Chronic opioid use except short-term use before cognitive assessments
- Current or recent use of immunosuppressant or immunomodulating drugs
- Additional exclusions for Down syndrome: clinical Alzheimer's dementia diagnosis, high DSQIID score, or low intelligence quotient (KBIT-2) score
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 to 74 weeks
Participants receive ACI-24.060 or placebo at predefined time points. Prodromal Alzheimer's disease participants receive treatment over 48 to 74 weeks depending on their study part and dose. Participants with Down syndrome receive treatment over 74 weeks.
Multiple visits at predefined time points over the treatment period
Trial Site Locations
Total: 26 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Withdrawn
2
K2 Medical Research The Villages LLC
Lady Lake, Florida, United States, 32159
Actively Recruiting
3
Charter Research, LLC
Orlando, Florida, United States, 32803
Actively Recruiting
4
Headlands Horizons LLC
Orlando, Florida, United States, 32819
Not Yet Recruiting
5
Charter Research, LLC
The Villages, Florida, United States, 32162
Actively Recruiting
6
Indiana University / IU Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
University of Kansas Medical Center Research Institute
Fairway, Kansas, United States, 66205-2513
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
The Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
10
Flourish Research
Matthews, North Carolina, United States, 28105
Not Yet Recruiting
11
Neurology Clinical, P.C.
Cordova, Tennessee, United States, 38018
Actively Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2103
Actively Recruiting
13
UT Health San Antonio
San Antonio, Texas, United States, 78229
Withdrawn
14
Fundació ACE, Institut Català de Neurociències Aplicades
Barcelona, Spain
Actively Recruiting
15
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
16
Hospital Universitario Virgen De Las Nieves
Granada, Spain
Withdrawn
17
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
18
Hospital Universitario de la Princesa
Madrid, Spain
Actively Recruiting
19
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Actively Recruiting
20
Hospital Universitario y Politécnico La Fe
Valencia, Spain
Actively Recruiting
21
Cambridge and Peterborough NHS Foundation Trust - Windsor Research Units
Cambridge, United Kingdom
Actively Recruiting
22
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Actively Recruiting
23
Re:Cognition Health Limited
London, United Kingdom
Actively Recruiting
24
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital
London, United Kingdom
Actively Recruiting
25
Oxford Health NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
26
NeuroClin Limited
Warrington, United Kingdom, WA3 7PB
Not Yet Recruiting
Research Team
O
Olivier Sol, MD
B
Benedicte Le
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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