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Monoclonal Antibodies

Sabirnetug for Alzheimer's Disease

Phase 1
Recruiting
Research Sponsored by Acumen Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) between 18 and 32 kg/m2 (inclusive), and weighs ≥54 kg
Male and female participants ≥ 50 years of age
Must not have
Shows signs/symptoms of dementia or has a parent with a known autosomal dominant mutation causing familial AD
Documented COVID-19 active infection or recent infection in the past 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up group 1: day 1 (predose) up to day 43 group 2: day 1 (predose) up to day 50
Awards & highlights

Summary

This trial is comparing the safety, side effects, and how the body processes two different forms of the drug Sabirnetug in healthy volunteers.

Who is the study for?
This trial is for healthy individuals aged 50 or above, with a BMI between 18 and 32 kg/m2, who don't smoke and are willing to stay at the Clinical Trial Unit (CTU) throughout the study. Women must not be able to bear children, and men must use contraception if their partners can get pregnant. People with significant health issues, drug abuse history, or recent infections like COVID-19 cannot join.
What is being tested?
The study tests Sabirnetug given intravenously (IV) versus Sabirnetug combined with rHuPH20 administered subcutaneously (SC). It aims to compare how safe they are, how well participants tolerate them, and how these drugs move through and out of the body in healthy people.
What are the potential side effects?
While specific side effects aren't listed here as it's testing on healthy volunteers initially for safety/tolerability/pharmacokinetics purposes rather than therapeutic effect; potential side effects could include reactions at injection sites, allergic responses to components of the drugs tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18 and 32, and I weigh at least 54 kg.
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I am 50 years old or older.
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I cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I show signs of dementia or have a parent with a genetic form of Alzheimer's.
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I have tested positive for COVID-19 recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~group 1: day 1 (predose) up to day 43 group 2: day 1 (predose) up to day 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and group 1: day 1 (predose) up to day 43 group 2: day 1 (predose) up to day 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Estimate blood levels of sabirnetug (ACU193)
Estimate blood levels of sabirnetug (ACU193), Clast
Estimate blood levels of sabirnetug (ACU193), concentration-time
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
16 participants receive sabirnetug + rHuPH20 by subcutaneous injection
Group II: Arm 1Experimental Treatment1 Intervention
12 participants receive sabirnetug by intravenous infusion

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Acumen PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
2,105 Total Patients Enrolled
Eric Siemers, M.D.Study DirectorAcumen Pharmaceuticals
~19 spots leftby Sep 2025
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