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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04524351 | Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's Patients | PHASE1 | COMPLETED | 75 | — | — | Aug 14, 2020 | Jan 31, 2022 | Feb 28, 2023 | 13 | United States |
Percent of patients with AEs in the Posiphen treatment arms compared to the Placebo group
| Arm | Type | Description |
|---|---|---|
| Posiphen, 80mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. |
| Posiphen, 40mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 40mg, taken once per day for 25±2 days. |
| Posiphen, 20mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 20mg, taken once per day for 25±2 days. |
| Posiphen, 10mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 10mg, taken once per day for 25±2 days. |
| Posiphen, 5mg (Parkinson's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 5mg, taken once per day for 25±2 days. |
| Placebo (Parkinson's Participants) | PLACEBO_COMPARATOR | Placebo Oral Capsule, taken once per day for 25±2 days. |
| Placebo (Alzheimer's Participants) | PLACEBO_COMPARATOR | Placebo Oral Capsule, taken once per day for 25±2 days. |
| Posiphen, 80mg (Alzheimer's Participants) | ACTIVE_COMPARATOR | Posiphen Oral Capsule, 80mg, taken once per day for 25±2 days. |
| Name | Type | Description |
|---|---|---|
| Posiphen | DRUG | Solid oral dosage form, capsule |
| Placebo | DRUG | Solid oral dosage form, capsule |
Inclusion Criteria Subjects must meet the following criteria: 1. Male or female aged 45 years and over. 2. Female participants must be of non-childbearing potential or post-menopausal for at least 2 consecutive years or surgically sterile (bilateral tubal ligation, hysterectomy or bilateral oophor...