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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05469360 | Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants | PHASE1 | ACTIVE NOT_RECRUITING | 38 | — | — | Feb 23, 2023 | Sep 24, 2027 | Jun 1, 2026 | 10 | Finland, France +2 |
Total tau protein levels in cerebrospinal fluid. More frequent timepoints might be added as deemed necessary per the site Investigator's judgment.
| Arm | Type | Description |
|---|---|---|
| NIO752 - Dose A - Cohort 1 | EXPERIMENTAL | A single intrathecal injection of Dose A |
| Matching placebo - Cohort 1 | PLACEBO_COMPARATOR | A single intrathecal injection of artificial cerebrospinal fluid (CSF) |
| NIO752 Dose B - Cohort 2 | EXPERIMENTAL | A single intrathecal injection of Dose B |
| Matching placebo - Cohort 2 | PLACEBO_COMPARATOR | A single intrathecal injection of artificial cerebrospinal fluid (CSF) |
| NIO752 OLE - Cohorts 1 and 2 | EXPERIMENTAL | Multiple intrathecal injections of Dose A |
| NIO752 - Dose C - Cohort 3 | EXPERIMENTAL | Two intrathecal injections of Dose C |
| Matching Placebo - Cohort 3 | PLACEBO_COMPARATOR | Two intrathecal injections of artificial cerebrospinal fluid (CSF) |
| NIO752 OLE - Cohort 3 | EXPERIMENTAL | Single intrathecal injection of Dose C |
| Name | Type | Description |
|---|---|---|
| NIO752 | DRUG | A single intrathecal (cerebrospinal) injection of NIO752 of Dose A |
| Matching placebo | DRUG | A single intrathecal injection of matching placebo |
Main Inclusion Criteria (placebo-controlled part): * Between 30 to 74 years old (both inclusive) at the time of informed consent. * A diagnosis of mild Alzheimer's Disease (AD) or mild cognitive impairment (MCI) due to AD at screening with at least a 6-month decline in cognitive function prior to s...