Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04931459 | A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD | PHASE1 | COMPLETED | 65 | — | — | Jun 21, 2021 | Jun 12, 2023 | Jul 19, 2023 | 17 | United States |
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...