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Also known as Nilotinib BE 84mg
Nilotinib BE · 1 trial · 1 indication
CDR-SB integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following a systematic patient examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. Prespecified severity anchors range from none = 0, questionable = 0.5, mild = 1, moderate = 2 to severe = 3 (the personal care domain omits the 0.5 score). "Sum of boxes" scoring methodology sums the score for each of the 6 domains and provides a value ranging from 0 to 18 that can change in increments of 0.5 or greater. Higher scores indicate greater disease severity. A positive change from baseline indicates clinical decline.
| Arm | Type | Description |
|---|---|---|
| Arm A: Placebo | PLACEBO_COMPARATOR | 425 subjects will be randomized to the placebo group. |
| Arm B: Experimental Low Dose | ACTIVE_COMPARATOR | 425 subjects to each of the Nilotinib BE, 84mg. |
| Arm C: Experimental High Dose | ACTIVE_COMPARATOR | 425 subjects to each of the Nilotinib BE, 112mg. |
| Name | Type | Description |
|---|---|---|
| Nilotinib BE 84mg | DRUG | 84 mg capsule |
| Nilotinib BE 112 mg | DRUG | 112 mg capsule |
| Placebo | DRUG | placebo capsule |
Inclusion Criteria: * 1- Diagnosis of dementia due to AD 2- Meet the National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria for dementia due to AD 3- Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline 4-...
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Nilotinib BE is an investigational small molecule being studied for the treatment of early Alzheimer's Disease. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its potential to modify the course of the disease in patients with early-stage Alzheimer's.
Nilotinib BE targets the ABL1 and BCR proteins, acting as an inhibitor of these molecular targets. By inhibiting ABL1 and BCR, the drug is believed to modulate pathways that may be relevant to Alzheimer's Disease pathology, though the exact mechanism of action in this context is still under investigation.
Nilotinib BE is being developed by Lantheus Holdings, Inc., a company publicly traded under the ticker symbol LNTH. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy and safety in patients with early Alzheimer's Disease.
Nilotinib BE is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 3 trial is designed to assess its efficacy and safety in subjects with early Alzheimer's Disease.
Nilotinib BE is being studied in a single Phase 3 clinical trial with the identifier NCT05143528. This randomized, double-blind, placebo-controlled trial is evaluating the efficacy and safety of Nilotinib BE in subjects with early Alzheimer's Disease and has an estimated enrollment of 1,275 participants.
Yes, Nilotinib BE is also known as Nilotinib BE 84mg. The 84mg designation refers to the specific dose strength being investigated in clinical trials. Both names refer to the same investigational drug being developed by Lantheus Holdings for early Alzheimer's Disease.