NCT04931459

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

A Phase 1 Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous ACU193 in Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Acumen Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 study is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when administered to participants diagnosed with Mild Cognitive Impairment (MCI) or Mild Dementia due to Alzheimer's disease (AD).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	ACU193	Intravenous ACU193
DRUG	Placebo	Intravenous Placebo

Timeline

• Start date: 2021-06-21
• Primary completion: 2023-06-12
• Completion: 2023-06-12
• First posted: 2021-06-18
• Last updated: 2023-07-19

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study