Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACU193 · 1 trial · 1 indication
Proportion of participants with AE, discontinuations due to AE or SAE, and withdrawals from the study due to AE
Incidence and clinically significant abnormal changes in clinical laboratory assessments (hematology, clinical chemistry, urinalysis)
Clinically significant abnormal changes in 12-Lead ECGs for PR, QRS, QT, QTcF, and QTcB
Presence of suicidal ideation as defined by a positive response to Question 5 on the C-SSRS suicide ideation section
Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)
| Arm | Type | Description |
|---|---|---|
| ACU193 Administration | EXPERIMENTAL | Participants will receive 1 to 3 doses of ACU193 by intravenous (IV) infusion. |
| Placebo Administration | PLACEBO_COMPARATOR | Participants receive 1 to 3 doses of matching ACU193 placebo by intravenous (IV) infusion. 2 participants per cohort will receive placebo. |
| Name | Type | Description |
|---|---|---|
| ACU193 | DRUG | Intravenous ACU193 |
| Placebo | DRUG | Intravenous Placebo |
Inclusion Criteria: 1. Males or females ages 55 to 90 (inclusive). 2. Participant weighs at least 41 kg (90 lbs) and no more than 113 kg (250 lbs) before study drug administration. 3. Female participants must be surgically sterile or be at least two years post-menopausal or at least one year post-m...
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ACU193 is an investigational small molecule being developed by Acumen Pharmaceuticals, Inc. for Alzheimer disease. It is designed to target soluble amyloid beta oligomers (AβOs), which are toxic protein aggregates implicated in the disease. ACU193 has completed a Phase 1 clinical trial and has received Fast Track designation from the FDA.
ACU193 is being developed for the treatment of Alzheimer disease, specifically for participants with mild cognitive impairment (MCI) or mild Alzheimer disease. It is an investigational therapy and has not been approved for any indication. The completed Phase 1 trial evaluated its safety, tolerability, and blood levels in this patient population.
ACU193 targets soluble amyloid beta oligomers (AβOs), which are small, soluble aggregates of the amyloid beta protein. These oligomers are considered a key toxic species in Alzheimer disease. By binding to AβOs, ACU193 aims to neutralize their downstream effects. The target is a protein class, and the drug is a small molecule.
ACU193 is being developed by Acumen Pharmaceuticals, Inc., a biopharmaceutical company focused on neuroscience. Acumen Pharmaceuticals trades on the Nasdaq under the ticker symbol ABOS. The company is the sole developer of ACU193 and has advanced it through a completed Phase 1 clinical trial.
ACU193 has completed a Phase 1 clinical trial. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 study was a randomized, double-blind, placebo-controlled trial that evaluated safety, tolerability, and blood levels in participants with MCI or mild Alzheimer disease.
ACU193 has been studied in one completed clinical trial, NCT04931459, titled "A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD." This Phase 1 trial enrolled 65 participants in the United States and was randomized, double-blind, and placebo-controlled. No active trials are currently listed.