Effects of ACI24.060 in subjects with prodromal Alzheimers disease and in adults with Down syndrome

• Research type

  Research Study

• Full 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

• IRAS ID

  1004601

• Contact name

  Bénédicte Le

• Contact email

  benedicte.le@acimmune.com

• Sponsor organisation

  AC Immune SA

• Eudract number

  2021-006195-17

• Clinicaltrials.gov Identifier

  NCT05462106

• Research summary

  In this research study (Part 1) an investigational study vaccine named ACI-24.060 is being tested in participants with prodromal Alzheimer’s disease (AD) and, at a later stage (Part 2) of the study, in adult participants with Down syndrome (DS). The medication is called investigational as it is not approved for marketing anywhere in the world as a treatment for any condition. A build-up of the protein Abeta (Aβ) in the brain is believed to play an important role in mental decline in people with Alzheimer’s disease and adults with Down syndrome. ACI-24.060 is intended to help reduce the quantity of Aβ in the brain and thereby slow down mental decline.
  In Part 1, male and female subjects aged 50 to 75 years of age with prodromal AD will participate

  In Part 2 non-demented male and female subjects with DS, 35 to 50 years of age will participate. Subjects with Down syndrome aged between 35 and 39 years may participate in case of prior evidence of amyloid results compatible with AD pathology.
  The overall study participation duration will be approximately 80 weeks in Part 1 and approximately 106 weeks in Part 2.
  A total of up to 60 prodromal AD subjects may be included in study Part 1 and up to 80 subjects with DS in Part 2.

  The main purpose of this study is to find out:
  • If ACI-24.060 is safe and well tolerated
  • If ACI-24.060 is able to provoke an immune response (elicit a related antibody response, as a study vaccine), also known as immunogenicity
  • How ACI-24.060 works inside the body of study participants (mechanism of action)

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  22/SC/0022

• Date of REC Opinion

  6 Apr 2022

• REC opinion

  Further Information Favourable Opinion