ACU193 for Early Alzheimer's Disease (ALTITUDE-AD Trial)

Phase 2

Recruiting

Research Sponsored by Acumen Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 80 weeks

Summary

This trial aims to test if ACU193 infusions given every four weeks can help slow down mental and physical decline in people with early Alzheimer's disease compared to a placebo.

Who is the study for?

This trial is for individuals with early Alzheimer's Disease who can attend regular infusions every four weeks. Specific eligibility details are not provided, but typically participants must meet certain health criteria and agree to follow the study procedures.

What is being tested?

The trial is testing ACU193, a drug given through an IV once a month, to see if it slows down memory loss and daily functioning decline in people with early Alzheimer's compared to a placebo (a treatment with no active drug).

What are the potential side effects?

Potential side effects of ACU193 are not detailed here, but common infusion-related reactions may include discomfort at the injection site, fever, chills, nausea, headache or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 80 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 80 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 80 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Secondary study objectives

Change from Baseline in ADAS-Cog13 Score

Change from Baseline in ADCS-iADL Score

Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB)

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label Extension (OLE) Period: sabirnetug 35 mg/kgExperimental Treatment1 Intervention

Participants will receive sabirnetug, 35 mg/kg, Q4W as an IV infusion during the OLE period.

Group II: Double-blind Treatment (DBT) Period: sabirnetug 35 mg/kgExperimental Treatment1 Intervention

Participants will receive sabirnetug, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period.

Group III: DBT Period: sabirnetug 50 mg/kgExperimental Treatment1 Intervention

Participants will receive sabirnetug, 35 mg/kg, for the first two doses, followed by sabirnetug, 50 mg/kg, Q4W as an IV infusion during the DBT period.

Group IV: DBT Period: PlaceboPlacebo Group1 Intervention

Participants will receive sabirnetug matching placebo, Q4W as an IV infusion during the DBT period.

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