CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
ACI-24 low dose +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02738450
NCT02738450Phase 1Completed
CompareCT.gov

A Phase Ib Multi-Center, Double-Blind, Randomized, Placebo-Controlled Dose Escalation Study of the Safety, Tolerability and Immunogenicity of ACI-24 in Adults With Down Syndrome

AC Immune SA·interventional·Posted Apr 14, 2016·Updated Oct 15, 2021

In Brief

A Phase 1 clinical trial evaluating ACI-24 low dose, ACI-24 high dose, and 1 other intervention for Down Syndrome. Completed, enrolled 20 participants across 4 sites.

Detailed Summary

The purpose of this study is to test in adults with Down Syndrome the safety, tolerability and immunogenicity of a vaccine, ACI-24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA), Alzheimer's Disease Cooperative Study (ADCS), LuMind IDSC Foundation

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 14, 2016
Enrollment StartMar 1, 2016
Primary CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.2 years ago

Interventions

ACI-24 low dosebiological

ACI-24 administered as a sterile suspension in PBS via s.c. injection.

ACI-24 high dosebiological

ACI-24 administered as a sterile suspension in PBS via s.c. injection.

Placebobiological

Placebo is a standard PBS sterile solution administrated via s.c. injection.