RecruitingAmyloid PlaqueBeta-AmyloidDSAD

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

Eligible age

35–85 yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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.

Sponsor: AC Immune SA

You may qualify if…

✓ Study Part 1a and Part 1b
✓ 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 screening.
✓ 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).

You may not qualify if…

✕ 1. 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.
✕ 2. 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.
✕ 3. 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.
✕ 4. 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.
✕ 5. History of meningitis or meningoencephalitis.
✕ 6. History of moderate or severe traumatic brain injury.
✕ 7. History or presence of inflammatory neurological disorders.
✕ 8. History or presence of immunological or autoimmune disorders.