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 (ABATE)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ Study Part 1

• 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 baseline.

⁃ 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 the 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.

Locations
United States
Arizona
Barrow Neurological Institute
RECRUITING
Phoenix
Indiana
Indiana University / IU Health
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center Research Institute
RECRUITING
Fairway
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Missouri
The Washington University
RECRUITING
St Louis
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
UT Health San Antonio
RECRUITING
San Antonio
Other Locations
Spain
Fundació ACE, Institut Català de Neurociències Aplicades
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Virgen De Las Nieves
WITHDRAWN
Granada
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario de la Princesa
RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
United Kingdom
Cambridge and Peterborough NHS Foundation Trust - Windsor Research Units
RECRUITING
Cambridge
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
Re:Cognition Health Limited
RECRUITING
London
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital
RECRUITING
London
Oxford Health NHS Foundation Trust
RECRUITING
Oxford
Contact Information
Primary
Olivier Sol, MD
clinicaltrials@acimmune.com
+41 21 345 9121
Backup
Benedicte Le
clinicaltrials@acimmune.com
+41 21 345 9121
Time Frame
Start Date: 2022-06-21
Estimated Completion Date: 2026-06
Participants
Target number of participants: 140
Treatments
Placebo_comparator: Placebo for Study Part 1 (Prodromal AD)
Prodromal AD participants receive placebo at predefined time points over 48 weeks
Experimental: ACI-24.060 at Dose A
Prodromal AD participants receive dose A of ACI-24.060 at predefined time points over 48 weeks
Experimental: ACI-24.060 at Dose B (Optional)
Prodromal AD participants receive dose B of ACI-24.060 at predefined time points over 48 weeks. This arm is optional.
Experimental: ACI-24.060 at Dose C (Optional)
Prodromal AD participants receive dose C of ACI-24.060 at predefined time points over 48 weeks. This arm is optional.
Experimental: ACI-24.060 at Dose D (Optional)
Prodromal AD participants receive dose D of ACI-24.060 at predefined time points over 48 weeks. This arm is optional.
Placebo_comparator: Placebo for Study Part 2 (Down syndrome)
Participants with Down syndrome receive placebo at predefined time points over 74 weeks
Experimental: ACI-24.060 at Dose X
Participants with Down syndrome receive dose X of ACI-24.060 at predefined time points over 74 weeks. Dose X will be a dose already tested in Study Part 1.
Experimental: ACI-24.060 at Dose Y (Optional)
Participants with Down syndrome may optionally receive a dose Y of ACI-24.060 at predefined time points over 74 weeks.
Sponsors
Collaborators: Worldwide Clinical Trials
Leads: AC Immune SA

This content was sourced from clinicaltrials.gov

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