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NMRA-323511 · 1 trial · 2 indications
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and Columbia Suicide Severity Rating Scale (C-SSRS) scores will be reported as TEAEs.
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as a TEAE. Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and C-SSRS scores will be reported as TEAEs.
The CMAI is a 29-item scale to assess the frequency of agitated behaviors. The 29 agitated behaviors are categorized into agitation factors, including aggressive behavior, physically non-aggressive behavior, and verbally agitated behavior. Each item is rated over the past 2 weeks on a 7-point scale ranging from "Never" (score of 1) to "Several times per hour" (score of 7). The CMAI total score is calculated as the sum of all 29 items and range from 29 (no agitation) to 203 (most severe agitation). A score \>45 is commonly regarded as clinically significant agitation.
| Arm | Type | Description |
|---|---|---|
| Part A: NMRA-323511 | EXPERIMENTAL | - |
| Part A: Placebo | PLACEBO_COMPARATOR | - |
| Part B: NMRA-323511 | EXPERIMENTAL | - |
| Part B: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| NMRA-323511 | DRUG | Participants will receive NMRA-323511 orally. |
| Placebo | DRUG | Participants will receive matching placebo tablets orally. |
Inclusion Criteria: Part A * Healthy participants * Age 65 to 80 years * Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 at the screening and check-in visit Part B * Participants aged 55 to 90 years * Diagnosis of probable AD or Alzheimer's clinical syndrome according to the National Institute of ...
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NMRA-323511 is an investigational small molecule being developed for Alzheimer's disease. It is being studied for its effects in healthy elderly individuals and adults with agitation associated with dementia due to Alzheimer's disease. The drug is in Phase 1 clinical development and is not yet approved.
NMRA-323511 is being developed by Neumora Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol NMRA. The drug is currently in Phase 1 clinical development for Alzheimer's disease.
NMRA-323511 is in Phase 1 clinical development. It is an investigational drug being studied for Alzheimer's disease and is not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development.
NMRA-323511 has one completed Phase 1 clinical trial, identified as NCT06546995. This study evaluated the effects of NMRA-323511 among healthy elderly adults and adults with agitation associated with dementia due to Alzheimer's disease. The trial was conducted in the United States and enrolled 87 participants.
NMRA-323511 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer's disease. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval and remains under clinical investigation.