AC Immune SA
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.
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.
Inclusion Criteria: 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…
Administration of Placebo in Study Part 1a
Administration of Dose A of ACI-24.060 in Study Part 1a
Administration of Dose B of ACI-24.060 in Study Part 1a
Administration of Dose C of ACI-24.060 in Study Part 1a
Administration of ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b
Administration of Placebo in Study Part 2
Administration of Dose A of ACI-24.060 in Study Part 2. Dose A will be a dose already tested in Study Part 1a
Administration of Dose B of ACI-24.060 in Study Part 2
Administration of Dose C of ACI-24.060 in Study Part 2
Administration of Placebo in Study Part 1b
Administration of ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b