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Vaccine

ACI-24.060 for Alzheimer's Disease and Down Syndrome

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

Must not have

Ongoing treatment with specific medications

Previous treatment with specific immunotherapies against AD

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking certain medications.

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I have been treated with immunotherapies for Alzheimer's disease.

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I have had an inflammatory neurological disorder.

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I cannot have a lumbar puncture due to health reasons.

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I have active hepatitis B or C.

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I have seizures that are not controlled by medication.

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My hypothyroidism is treated but my medication dose isn't stable yet.

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I regularly use opioid painkillers.

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I am receiving a lumbar puncture and specific medications.

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I am currently using or have recently used drugs that affect my immune system.

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I have had meningitis or meningoencephalitis in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

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 / 14Eligibility criteria met

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Who is running the clinical trial?

AC Immune SALead Sponsor

6 Previous Clinical Trials

269 Total Patients Enrolled

Worldwide Clinical TrialsOTHER

64 Previous Clinical Trials

14,635 Total Patients Enrolled

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