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Monoclonal Antibodies

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

Phase 2 & 3
Recruiting
Led By Eric Siemers, MD
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
Awards & highlights

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.Check my eligibility
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).See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Secondary outcome measures
CSF Concentrations of ACU193 in a Subset of Participants
Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids
Change from Baseline in ADAS-Cog13 Score
+29 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label Extension (OLE) Period: ACU193 35 mg/kgExperimental Treatment1 Intervention
Participants will receive ACU193, 35 mg/kg, Q4W as an IV infusion during the OLE period.
Group II: Double-blind Treatment (DBT) Period: ACU193 35 mg/kgExperimental Treatment1 Intervention
Participants will receive ACU193, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period.
Group III: DBT Period: ACU193 50 mg/kgExperimental Treatment1 Intervention
Participants will receive ACU193, 35 mg/kg, for the first two doses, followed by AUC193, 50 mg/kg, Q4W as an IV infusion during the DBT period.
Group IV: DBT Period: PlaceboPlacebo Group1 Intervention
Participants will receive AUC193 matching placebo, Q4W as an IV infusion during the DBT period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACU193
2021
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Acumen PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
Eric Siemers, MDPrincipal InvestigatorAcumen Pharmaceuticals
2 Previous Clinical Trials
115 Total Patients Enrolled
~1360 spots leftby Jan 2031
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