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Vaccine

ACI-24.060 at Dose D (Optional) for Alzheimer's Disease

Phase 1 & 2

Recruiting

Led By Michael Rafii, MD

Research Sponsored by AC Immune SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Study Part 2: Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of the chromosome 21

Study Part 1: Diagnosis of prodromal AD: MCI due to AD according to NIA-AA criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to w48 (study part 1) and to w100 (study part 2)

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a drug called ACI-24.060 in people with early Alzheimer's disease and in adults with Down syndrome who do not have dementia.

Who is the study for?

This trial is for adults aged 50-75 with early-stage Alzheimer's (prodromal AD) and a specific type of dementia score, or non-demented adults aged 35-50 with Down syndrome. Participants must have evidence of amyloid brain plaques and can be on stable Alzheimer's medications.Check my eligibility

What is being tested?

The study tests various doses of ACI-24.060 against a placebo to evaluate its safety, how well it's tolerated, the immune response it generates, and its effects on brain plaque in those with prodromal Alzheimer’s Disease and adults with Down Syndrome.See study design

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site, flu-like symptoms due to immune response, headaches or dizziness. Side effects will vary based on individual tolerance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Down syndrome with a confirmed genetic diagnosis.

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I have been diagnosed with early-stage Alzheimer's disease.

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I am between 50 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to w48 (study part 1) and to w100 (study part 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to w48 (study part 1) and to w100 (study part 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to w48 (study part 1) and to w100 (study part 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Anti-Abeta antibody titers in blood

Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)

Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related)

+2 more

Secondary outcome measures

Change from baseline in Anti-Abeta antibody titers

Other outcome measures

Complementarity Determining Regions

Alzheimer's Disease

Down Syndrome

+5 more

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: ACI-24.060 at Dose Y (Optional)Experimental Treatment1 Intervention

Participants with Down syndrome may optionally receive a dose Y of ACI-24.060 at predefined time points over 74 weeks.

Group II: ACI-24.060 at Dose XExperimental Treatment1 Intervention

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.

Group III: ACI-24.060 at Dose D (Optional)Experimental Treatment1 Intervention

Prodromal AD participants receive dose D of ACI-24.060 at predefined time points over 48 weeks. This arm is optional.

Group IV: ACI-24.060 at Dose C (Optional)Experimental Treatment1 Intervention

Prodromal AD participants receive dose C of ACI-24.060 at predefined time points over 48 weeks. This arm is optional.

Group V: ACI-24.060 at Dose B (Optional)Experimental Treatment1 Intervention

Prodromal AD participants receive dose B of ACI-24.060 at predefined time points over 48 weeks. This arm is optional.

Group VI: ACI-24.060 at Dose AExperimental Treatment1 Intervention

Prodromal AD participants receive dose A of ACI-24.060 at predefined time points over 48 weeks

Group VII: Placebo for Study Part 2 (Down syndrome)Placebo Group1 Intervention

Participants with Down syndrome receive placebo at predefined time points over 74 weeks

Group VIII: Placebo for Study Part 1 (Prodromal AD)Placebo Group1 Intervention

Prodromal AD participants receive placebo at predefined time points over 48 weeks

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AC Immune SALead Sponsor

5 Previous Clinical Trials

239 Total Patients Enrolled

Worldwide Clinical TrialsOTHER

61 Previous Clinical Trials

14,247 Total Patients Enrolled

Michael Rafii, MDPrincipal InvestigatorUniversity of Southern California, Alzheimer's Therapeutic Research Institute, 9860 Mesa Rim Rd, San Diego, CA 92121, USA

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study include participants who are above the age of sixty?

"To participate in this study, individuals must be between 35 and 85 years of age."

Answered by AI

Are patients currently able to enroll in this ongoing study?

"The clinical trial, currently open for participant recruitment as per the information available on clinicaltrials.gov, was first listed on 6/21/2022 and last revised on 2/20/2024."

Answered by AI

At how many different sites is this medical trial being conducted?

"At this moment, patient recruitment is ongoing at 17 sites. Major cities like Madrid, Indianapolis, and Fairway are included in addition to various other locations. Opting for the nearest site can help reduce travel requirements upon enrollment."

Answered by AI

What is the collective count of individuals actively involved in this research trial?

"A total of 140 eligible individuals are needed to partake in this research endeavor. Interested patients can join the study from diverse locations such as Hospital Universitario de la Princesa in Madrid, Indiana University / IU Health in Indianapolis, and Kansas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

2022. "A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462106.

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