Amyloid PlaquePhase 1/2NCT05462106
A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
A Phase 1/2 study testing ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a and ACI-24.060 at Dose C in Study Part 1a in people with Amyloid Plaque and Beta-Amyloid, run by AC Immune SA at 26 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Amyloid Plaque, Beta-Amyloid, DSAD
- What is being tested?
- ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a and ACI-24.060 at Dose C in Study Part 1a
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 21 Jun 2022to Apr 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study Part 1a and Part 1b
- Age ≥50 and ≤85 years at screening.
- Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria.
- PET scan at screening consistent with the presence of amyloid pathology.
- Clinical Dementia Rating (CDR)-Global Score of 0.5.
- 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 screening.
Show all 12Show fewer
- Study Part 2
- 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).
- Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of chromosome 21.
- PET scan at screening consistent with the presence of amyloid pathology.
- Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification.
- Subjects must have a study partner who has direct and regular contact, at least 10 hours per week, with the subject and who is able to provide reliable answers to questions related to the subject, according to the study investigator.
Who cannot join
- Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study treatment (eg, moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.
- DSM-5 criteria for substance use disorders drug or alcohol abuse or dependence (with the exception of tobacco use disorder) currently met within the past 5 years.
- History or presence of uncontrolled seizures. If there is a history of seizures, they must be well controlled, with no occurrence of seizures in the 2 years before study screening. The use of antiepileptic medications is permitted.
- Concomitant or history of clinically significant and/or unstable psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and/or non-hemorrhagic stroke). Subjects with a history of major depressive disorder may be included if they have been free of major episodes for at least 1 year before screening.
- History of meningitis or meningoencephalitis.
- History of moderate or severe traumatic brain injury.
Show all 34Show fewer
- History or presence of inflammatory neurological disorders.
- History or presence of immunological or autoimmune disorders.
- History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and/or medications.
- Significant risk of suicide, defined using the C-SSRS as the subject answering "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior within the past 12 months.
- MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or evidence of a previous macro-hemorrhage or showing more than 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"). Evidence of space occupying lesions other than benign meningioma of less than 1 cm diameter, more than 2 lacunar infarcts, or 1 single infarct larger than 1 cm in diameter. Screening MRI scan showing structural evidence of alternative pathology not consistent with AD and is considered to be at the origin of subject's symptoms.
- Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.
- Subjects with a positive Human Immunodeficiency Virus (HIV-1 and 2) test at screening.
- Subjects with clinical or laboratory evidence of active hepatitis B or C at screening (eg, HBV or HCV antigens).
- Subjects with positive syphilis serology consistent with active syphilis at screening.
- Subjects with presence of antibody titers related to immunological or autoimmune disorders at screening.
- MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI and/or severe claustrophobia.
- Any contraindication for PET scan imaging.
- Any contraindication to lumbar puncture in subjects undergoing this procedure (note: lumbar puncture is optional in subjects with DS).
- Previous treatment with ACI-24 or any other active immunotherapy against AD at any time in the past unless there is firm evidence that the subject received placebo only and the placebo formulation is not expected to induce any specific immune response.
- Previous treatment with any investigational and/or marketed passive immunotherapy against AD within 6 months before screening or 5 half-lives, whichever is longer, unless there is firm evidence that the subject received placebo only.
- Ongoing treatment with any approved anti-amyloid passive immunotherapy for Alzheimer's disease.
- Use of acetylcholinesterase inhibitor or glutamatergic drugs (eg, memantine, topiramate, lamotrigine) if not on stable dose for at least 2 months before screening.
- Any vaccine, either live or not, including but not limited to influenza or COVID-19 vaccine, received within 4 weeks before randomization.
- Subjects with treated hypothyroidism not on a stable dose of replacement medication for at least 2 months before screening and having clinically significant abnormal serum T4 and/or thyroid stimulating hormone at screening.
- Subjects undergoing lumbar puncture and being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower.
- Use of antidepressants (other than selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors at stable dose); typical antipsychotics; γ-aminobutyric acid agonists (eg, gabapentin); or stimulants (eg, methylphenidate, modafinil). Stable doses of atypical antipsychotics or benzodiazepines are only allowed if this is not considered to influence the safety and the efficacy of the study treatment according to the site investigator and the sponsor medical monitor.
- Chronic use of opioid analgesics. A limited treatment duration for acute conditions until 24 hours before cognitive assessment is allowed.
- Current use of immunosuppressant or immunomodulating drugs or their use within the 6 months before study screening. Current use of oral steroids or their use within the 3 months before study screening.
- Additional Exclusion Criteria in Study Part 2
- The following are exclusion criteria at the time of randomization but will not be considered as exclusionary after treatment assignment:
- Clinical diagnosis of AD dementia in DS as per International Classification of Diseases 10 (ICD-10).
- DSQIID >20.
- Intelligence quotient score <40 (KBIT-2).
Trial locations and contacts
26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 3 countries
United States13 sites, 6 recruiting
- Active, not recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Neurology Clinical, P.C.
Cordova, Tennessee, 38018
- Active, not recruiting
University of Kansas Medical Center Research Institute
Fairway, Kansas, 66205-2513
- Active, not recruiting
Indiana University / IU Health
Indianapolis, Indiana, 46202
- Recruiting
K2 Medical Research The Villages LLC
Lady Lake, Florida, 32159
- Not yet recruiting
Flourish Research
Matthews, North Carolina, 28105
- Active, not recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2103
- Recruiting
Charter Research, LLC
Orlando, Florida, 32803
- Not yet recruiting
Headlands Horizons LLC
Orlando, Florida, 32819
- Withdrawn
Barrow Neurological Institute
Phoenix, Arizona, 85013
- Withdrawn
UT Health San Antonio
San Antonio, Texas, 78229
- Active, not recruiting
The Washington University
St Louis, Missouri, 63130
- Recruiting
Charter Research, LLC
The Villages, Florida, 32162
Spain7 sites, 4 recruiting
- Recruiting
Fundació ACE, Institut Català de Neurociències Aplicades
Barcelona
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
- Withdrawn
Hospital Universitario Virgen De Las Nieves
Granada
- Recruiting
Hospital Clínico San Carlos
Madrid
- Active, not recruiting
Hospital Universitario de la Princesa
Madrid
- Active, not recruiting
Hospital Universitario Marqués de Valdecilla
Santander
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia
United Kingdom6 sites, 5 recruiting
- Active, not recruiting
Cambridge and Peterborough NHS Foundation Trust - Windsor Research Units
Cambridge
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool
- Recruiting
Re:Cognition Health Limited
London
- Recruiting
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital
London
- Recruiting
Oxford Health NHS Foundation Trust
Oxford
- Not yet recruiting
NeuroClin Limited
Warrington, WA3 7PB
About this study
Official title: A Phase 1b/2, Multicenter, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-24.060 in Subjects With Prodromal Alzheimer's Disease and in Adults With Down Syndrome (ABATE)
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.
Read the detailed description
This phase 1b/2 study will be in 2 parts. Study Part 1 will involve subjects with prodromal Alzheimer's disease and is divided into Part 1a and Part 1b. Study Part 2 will involve subjects with Down syndrome.
- Being tested
- Placebo (Study Part 1a), ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a, ACI-24.060 at Dose C in Study Part 1a, ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
- Keywords
- Dementia, Brain Diseases, Central Nervous System Diseases, Amyloid Plaque, Beta-Amyloid, Down syndrome, Immunogenicity, active immunotherapy, immune response, anti-amyloid therapy, DSAD, Alzheimer's disease
- Medical subject headings
- Plaque, Amyloid, Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Study Part 1a)Biological
Administration of Placebo in Study Part 1a
ACI-24.060 at Dose A in Study Part 1aBiological
Administration of Dose A of ACI-24.060 in Study Part 1a
ACI-24.060 at Dose B in Study Part 1aBiological
Administration of Dose B of ACI-24.060 in Study Part 1a
ACI-24.060 at Dose C in Study Part 1aBiological
Administration of Dose C of ACI-24.060 in Study Part 1a
ACI-24.060 with an additional adjuvant at Dose D in Study Part 1bBiological
Administration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
Placebo (Study Part 2)Biological
Administration of Placebo in Study Part 2
ACI-24.060 at Dose A in Study Part 2Biological
Administration of Dose A of ACI-24.060 in Study Part 2. Dose A will be a dose already tested in Study Part 1a
ACI-24.060 at Dose B in Study Part 2Biological
Administration of Dose B of ACI-24.060 in Study Part 2
ACI-24.060 at Dose C in Study Part 2Biological
Administration of Dose C of ACI-24.060 in Study Part 2
Placebo (Study Part 1b)Biological
Administration of Placebo in Study Part 1b
ACI-24.060 with an additional adjuvant at Dose E in Study Part 1bBiological
Administration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b
| Study group | Role | What they receive |
|---|---|---|
| Placebo for Study Part 1a (Prodromal AD) | Placebo comparator | Prodromal AD participants receive placebo at predefined time points over 48 weeks Receives: Biological: Placebo (Study Part 1a) |
| ACI-24.060 at Dose A in Prodromal AD | Experimental | Prodromal AD participants receive dose A of ACI-24.060 at predefined time points over 48 weeks Receives: Biological: ACI-24.060 at Dose A in Study Part 1a |
| ACI-24.060 at Dose B in Prodromal AD | Experimental | Prodromal AD participants receive dose B of ACI-24.060 at predefined time points over 48 weeks. Receives: Biological: ACI-24.060 at Dose B in Study Part 1a |
| ACI-24.060 at Dose C in Prodromal AD | Experimental | Prodromal AD participants receive dose C of ACI-24.060 at predefined time points over 48 weeks. Receives: Biological: ACI-24.060 at Dose C in Study Part 1a |
| ACI-24.060 with an additional adjuvant at Dose D in Prodromal AD | Experimental | Prodromal AD participants receive ACI-24.060 with an additional adjuvant at Dose D at predefined time points over 74 weeks. Receives: Biological: ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b |
| Placebo for Study Part 2 (Down syndrome) | Placebo comparator | Participants with Down syndrome receive placebo at predefined time points over 74 weeks Receives: Biological: Placebo (Study Part 2) |
| ACI-24.060 at Dose A in Down syndrome | Experimental | Participants with Down syndrome receive dose A of ACI-24.060 at predefined time points over 74 weeks. Dose A will be a dose already tested in Study Part 1. Receives: Biological: ACI-24.060 at Dose A in Study Part 2 |
| ACI-24.060 at Dose B in Down syndrome | Experimental | Participants with Down syndrome may optionally receive a dose B of ACI-24.060 at predefined time points over 74 weeks. Receives: Biological: ACI-24.060 at Dose B in Study Part 2 |
| ACI-24.060 at Dose C in Down syndrome | Experimental | Participants with Down syndrome receive dose C of ACI-24.060 at predefined time points over 74 weeks. Dose C will be a dose already tested in Study Part 1. Receives: Biological: ACI-24.060 at Dose C in Study Part 2 |
| ACI-24.060 with an additional adjuvant at Dose E in Prodromal AD | Experimental | Prodromal AD participants receive ACI-24.060 with an additional adjuvant at Dose E at predefined time points over 74 weeks. Receives: Biological: ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b |
| Placebo for Study Part 1b (Prodromal AD) | Placebo comparator | Prodromal AD participants receive placebo at predefined time points over 74 weeks Receives: Biological: Placebo (Study Part 1b) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)
Measured: 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)
Measured: From Screening to Week 100 (Study Part 2)
Number of participants with abnormal MRI results
Measured: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Number of participants with abnormal MRI results
Measured: From Baseline to Week 100 (Study Part 2)
Number of participants with abnormal physical and neurological examination results
Measured: 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
Measured: From Baseline to Week 100 (Study Part 2)
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: 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)
Measured: From Baseline to Week 100 (Study Part 2)
Change from baseline in Anti-Abeta antibody titers in blood
Measured: From Baseline to Week 100 (Study Part 2)
Secondary outcomes (2)
Change from baseline in Anti-Abeta antibody titers
Measured: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline on brain amyloid levels
Brain amyloid load measured via PET imaging. An increase indicates a worsening.
Measured: From Baseline to W100 (Study Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start21 Jun 2022
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyloid PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Immune SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Michael Rafii, MD, Principal investigator, University of Southern California, Alzheimer's Therapeutic Research Institute, 9860 Mesa Rim Rd, San Diego, CA 92121, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462106
- Sponsor's protocol ID
- ACI-24-AD-DS-2102
- Other IDs
- 2021-006195-17, 2022-500069-29-00
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multicenter, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-24.060 in Subjects With Prodromal Alzheimer's Disease and in Adults With Down Syndrome (ABATE)
- ClinicalTrials.gov ID
- NCT05462106
- Acronym / sponsor ID
- ACI-24-AD-DS-2102
- Keywords
- Dementia, Brain Diseases, Central Nervous System Diseases, Amyloid Plaque, Beta-Amyloid, Down syndrome, Immunogenicity, active immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- AC Immune SAIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase 1b/2 study will be in 2 parts. Study Part 1 will involve subjects with prodromal Alzheimer's disease and is divided into Part 1a and Part 1b. Study Part 2 will involve subjects with Down syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Placebo for Study Part 1a (Prodromal AD) | Placebo comparator | Biological: Placebo (Study Part 1a)Prodromal AD participants receive placebo at predefined time points over 48 weeks |
| ACI-24.060 at Dose A in Prodromal AD | Experimental | Biological: ACI-24.060 at Dose A in Study Part 1aProdromal AD participants receive dose A of ACI-24.060 at predefined time points over 48 weeks |
| ACI-24.060 at Dose B in Prodromal AD | Experimental | Biological: ACI-24.060 at Dose B in Study Part 1aProdromal AD participants receive dose B of ACI-24.060 at predefined time points over 48 weeks. |
| ACI-24.060 at Dose C in Prodromal AD | Experimental | Biological: ACI-24.060 at Dose C in Study Part 1aProdromal AD participants receive dose C of ACI-24.060 at predefined time points over 48 weeks. |
| ACI-24.060 with an additional adjuvant at Dose D in Prodromal AD | Experimental | Biological: ACI-24.060 with an additional adjuvant at Dose D in Study Part 1bProdromal AD participants receive ACI-24.060 with an additional adjuvant at Dose D at predefined time points over 74 weeks. |
| Placebo for Study Part 2 (Down syndrome) | Placebo comparator | Biological: Placebo (Study Part 2)Participants with Down syndrome receive placebo at predefined time points over 74 weeks |
| ACI-24.060 at Dose A in Down syndrome | Experimental | Biological: ACI-24.060 at Dose A in Study Part 2Participants with Down syndrome receive dose A of ACI-24.060 at predefined time points over 74 weeks. Dose A will be a dose already tested in Study Part 1. |
| ACI-24.060 at Dose B in Down syndrome | Experimental | Biological: ACI-24.060 at Dose B in Study Part 2Participants with Down syndrome may optionally receive a dose B of ACI-24.060 at predefined time points over 74 weeks. |
| ACI-24.060 at Dose C in Down syndrome | Experimental | Biological: ACI-24.060 at Dose C in Study Part 2Participants with Down syndrome receive dose C of ACI-24.060 at predefined time points over 74 weeks. Dose C will be a dose already tested in Study Part 1. |
| ACI-24.060 with an additional adjuvant at Dose E in Prodromal AD | Experimental | Biological: ACI-24.060 with an additional adjuvant at Dose E in Study Part 1bProdromal AD participants receive ACI-24.060 with an additional adjuvant at Dose E at predefined time points over 74 weeks. |
| Placebo for Study Part 1b (Prodromal AD) | Placebo comparator | Biological: Placebo (Study Part 1b)Prodromal AD participants receive placebo at predefined time points over 74 weeks |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Study Part 1a and Part 1b
- Age ≥50 and ≤85 years at screening.
- Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria.
- PET scan at screening consistent with the presence of amyloid pathology.
- Clinical Dementia Rating (CDR)-Global Score of 0.5.
Key exclusion criteria (34 listed)
- Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of the study treatment (eg, moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.
- DSM-5 criteria for substance use disorders drug or alcohol abuse or dependence (with the exception of tobacco use disorder) currently met within the past 5 years.
- History or presence of uncontrolled seizures. If there is a history of seizures, they must be well controlled, with no occurrence of seizures in the 2 years before study screening. The use of antiepileptic medications is permitted.
- Concomitant or history of clinically significant and/or unstable psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and/or non-hemorrhagic stroke). Subjects with a history of major depressive disorder may be included if they have been free of major episodes for at least 1 year before screening.
- History of meningitis or meningoencephalitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (Study Part 1a)Administration of Placebo in Study Part 1a | Biological | Placebo for Study Part 1a (Prodromal AD) |
| ACI-24.060 at Dose A in Study Part 1aAdministration of Dose A of ACI-24.060 in Study Part 1a | Biological | ACI-24.060 at Dose A in Prodromal AD |
| ACI-24.060 at Dose B in Study Part 1aAdministration of Dose B of ACI-24.060 in Study Part 1a | Biological | ACI-24.060 at Dose B in Prodromal AD |
| ACI-24.060 at Dose C in Study Part 1aAdministration of Dose C of ACI-24.060 in Study Part 1a | Biological | ACI-24.060 at Dose C in Prodromal AD |
| ACI-24.060 with an additional adjuvant at Dose D in Study Part 1bAdministration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b | Biological | ACI-24.060 with an additional adjuvant at Dose D in Prodromal AD |
| Placebo (Study Part 2)Administration of Placebo in Study Part 2 | Biological | Placebo for Study Part 2 (Down syndrome) |
| ACI-24.060 at Dose A in Study Part 2Administration 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 A in Down syndrome |
| ACI-24.060 at Dose B in Study Part 2Administration of Dose B of ACI-24.060 in Study Part 2 | Biological | ACI-24.060 at Dose B in Down syndrome |
| ACI-24.060 at Dose C in Study Part 2Administration of Dose C of ACI-24.060 in Study Part 2 | Biological | ACI-24.060 at Dose C in Down syndrome |
| Placebo (Study Part 1b)Administration of Placebo in Study Part 1b | Biological | Placebo for Study Part 1b (Prodromal AD) |
| ACI-24.060 with an additional adjuvant at Dose E in Study Part 1bAdministration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b | Biological | ACI-24.060 with an additional adjuvant at Dose E in Prodromal AD |
Primary outcome
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)
2 secondary outcomes
Change from baseline in Anti-Abeta antibody titers
Time frame: From Baseline to Week 74 (Study Part 1a) and from Baseline to Week 100 (Study Part 1b)
Change from baseline on brain amyloid levels
Time frame: From Baseline to W100 (Study Part 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Amyloid Plaque
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease
Alzheimer Disease, Amyloid
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 2
A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
Atherosclerosis, Coronary Artery Disease
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Rafii, MD principal investigator
University of Southern California, Alzheimer's Therapeutic Research Institute, 9860 Mesa Rim Rd, San Diego, CA 92121, USA
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACI-24.060 at Dose A in Study Part 1a, ACI-24.060 at Dose B in Study Part 1a and ACI-24.060 at Dose C in Study Part 1a in people with Amyloid Plaque and Beta-Amyloid, run by AC Immune SA at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Sol, MD (+41 21 345 9121, clinicaltrials@acimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.