A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Amyloid Plaque, Beta-Amyloid, DSAD, Prodromal Alzheimer's Disease, Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT05462106

Run by

AC Immune SA

People needed

304

Starts

2022-06-21

Expected to finish

2029-04-01

Last updated by the study team

2026-07-10

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• K2 Medical Research The Villages LLC — Lady Lake, Florida, United States (enrolling)
• Hospital Clínico San Carlos — Madrid, Spain (enrolling)
• Neurology Clinical, P.C. — Cordova, Tennessee, United States (enrolling)
• Charter Research, LLC — The Villages, Florida, United States (enrolling)
• Hospital Universitario y Politécnico La Fe — Valencia, Spain (enrolling)
• Charter Research, LLC — Orlando, Florida, United States (enrolling)
• Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom (enrolling)
• Re:Cognition Health Limited — London, United Kingdom (enrolling)
• South London and Maudsley NHS Foundation Trust of The Maudsley Hospital — London, United Kingdom (enrolling)
• Oxford Health NHS Foundation Trust — Oxford, United Kingdom (enrolling)
• Fundació ACE, Institut Català de Neurociències Aplicades — Barcelona, Spain (enrolling)
• Cambridge and Peterborough NHS Foundation Trust - Windsor Research Units — Cambridge, United Kingdom
• Barrow Neurological Institute — Phoenix, Arizona, United States
• NeuroClin Limited — Warrington, United Kingdom
• Headlands Horizons LLC — Orlando, Florida, United States
• Indiana University / IU Health — Indianapolis, Indiana, United States
• University of Kansas Medical Center Research Institute — Fairway, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Washington University — St Louis, Missouri, United States
• Flourish Research — Matthews, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Health San Antonio — San Antonio, Texas, United States
• Hospital Universitario Virgen De Las Nieves — Granada, Spain
• Hospital Universitario de la Princesa — Madrid, Spain

Full record on ClinicalTrials.gov

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