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 for the treatment of Alzheimer Disease. It is intended for use in patients with mild cognitive impairment or mild Alzheimer's disease. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
ACU193 targets amyloid beta, a protein that forms plaques in the brains of Alzheimer's disease patients. By binding to this target, the drug aims to modify the disease process. This mechanism is being evaluated in early-stage clinical trials to assess its safety and efficacy.
ACU193 is being developed by Acumen Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ABOS. Acumen is conducting clinical trials to evaluate the drug's potential as a treatment for Alzheimer's disease.
ACU193 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for commercial use. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
ACU193 has been studied in one clinical trial, identified as NCT04931459. This Phase 1 study evaluated the safety, tolerability, and blood levels of ACU193 in participants with mild cognitive impairment or mild Alzheimer's disease. The trial was completed in the United States and enrolled 65 participants.
ACU193 is a unique investigational compound developed by Acumen Pharmaceuticals. It is not known to be the same as any other marketed drug. Its distinct mechanism and development program differentiate it from other Alzheimer's disease treatments currently available.