Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NIO752 · 1 trial · 2 indications
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...
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NIO752 is an investigational small molecule being studied for the treatment of early Alzheimer's Disease, including mild cognitive impairment. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
The molecular target of NIO752 has not been disclosed. It is a small molecule being developed by Novartis for Alzheimer's Disease, but its specific mechanism of action is not publicly available.
NIO752 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 1 clinical trial to evaluate the drug in early Alzheimer's Disease.
NIO752 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is active but not recruiting participants.
NIO752 is being studied in a single Phase 1 clinical trial with the identifier NCT05469360. This randomized, double-blind, placebo-controlled study is evaluating the safety, tolerability, pharmacodynamics, and pharmacokinetics of NIO752 in participants with early Alzheimer's Disease.
No alternative names for NIO752 have been disclosed. It is a distinct investigational small molecule being developed by Novartis for Alzheimer's Disease, and no other names or aliases are currently associated with it.