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A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD (INTERCEPT-AD Trial)

Phase 1
Waitlist Available
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 45 days
Treatment Varies
Follow Up baseline up to 20 weeks (sad); 14, 18 or 28 weeks (mad)

Summary

This trial tests an IV drug called ACU193 to see if it is safe and how it affects people. It focuses on patients with early-stage Alzheimer's disease. The study will look at how the drug moves through the body and its effects.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 45 days
Treatment ~ Varies
Follow Up ~baseline up to 20 weeks (sad); 14, 18 or 28 weeks (mad)
This trial's timeline: 45 days for screening, Varies for treatment, and baseline up to 20 weeks (sad); 14, 18 or 28 weeks (mad) 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 in Clinical Laboratory Tests
Changes in 12-Lead ECGs
Changes in Magnetic Resonance Imaging (MRI)
+2 more
Secondary study objectives
Estimate Blood Levels of ACU193
Estimate Clearance of ACU193
Estimate Maximum Blood Levels of ACU193
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ACU193 AdministrationExperimental Treatment1 Intervention
Participants will receive 1 to 3 doses of ACU193 by intravenous (IV) infusion.
Group II: Placebo AdministrationPlacebo Group1 Intervention
Participants receive 1 to 3 doses of matching ACU193 placebo by intravenous (IV) infusion. 2 participants per cohort will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACU193
2021
Completed Phase 1
~70

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
28,192,052 Total Patients Enrolled
Acumen PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
568 Total Patients Enrolled
James Senetar, PharmDStudy DirectorAcumen Pharmaceuticals, Inc.
Russell Barton, MSStudy DirectorAcumen Pharmaceuticals, Inc.
1 Previous Clinical Trials
164 Total Patients Enrolled
Eric Siemers, MDPrincipal InvestigatorAcumen Pharmaceuticals, Inc.
2 Previous Clinical Trials
590 Total Patients Enrolled
Russell BartonStudy DirectorAcumen Pharmaceuticals, Inc.
Alyssa CarrollStudy DirectorAcumen Pharmaceuticals, Inc.
~15 spots leftby Dec 2025
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