| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05143528 | Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease | PHASE3 | NOT YET_RECRUITING | 1,275 | — | — | Feb 1, 2022 | Jun 1, 2026 | Dec 3, 2021 | - | — |
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-...