ClinicaliQ Trial Snapshot
- A Study to Assess the Effects of ACI-24.060 in Alzheimer’s Disease and in Down Syndrome (ABATE Study) — Recruiting • Phase I • Neurology • NCT05462106.
- What is being tested: ACI-24.060, an investigational therapeutic agent, is being evaluated for its safety, tolerability, immunogenicity, and pharmacodynamic effects in two distinct populations: patients with prodromal Alzheimer's disease and cognitively unaffected adults with Down syndrome.
- Patient eligibility overview: The study enrolls two specific groups—individuals in the early symptomatic stages of Alzheimer's disease (prodromal stage) and non-demented adults with Down syndrome—allowing investigation of the agent's potential across different aetiologies of cognitive decline risk.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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.
Eligibility Snapshot
- : 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). 2. Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of chromosome 21. 3. PET scan at screening consistent with the presence of amyloid pathology. 4. Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification. 5. Subjects must have a study partner who has direct and regular contact, at least 10 hours per week, with the…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.