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This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among healthy elderly.
Part B is a multicenter, randomized, double-blinded, placebo-controlled, parallel-group cohort to evaluate the safety, tolerability, and efficacy of NMRA-323511 among adults with Agitation Associated with Dementia due to Alzheimer's Disease.
Part A consists of a Screening Period (up to 28 days), a 10-day Treatment Period, and a 10- day Follow-up clinic visit after last dose of study treatment.
Part B consists of a Screening Period (up to 28 days), an 8-week Treatment Period, and a 10-day Follow-up clinic visit after last dose of study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: NMRA-323511 | Experimental |
| |
| Part A: Placebo | Placebo Comparator |
| |
| Part B: NMRA-323511 | Experimental |
| |
| Part B: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMRA-323511 | Drug | Participants will receive NMRA-323511 orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales | 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. | Up to 53 days |
| Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales | 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. | Up to Week 10 |
| Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score | 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. | Baseline to Week 8 |
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Inclusion Criteria:
Part A
Part B
Exclusion Criteria:
Part A
Part B
Note: Other protocol defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neumora Investigator Site | Chandler | Arizona | 85286 | United States | ||
| Neumora Investigator Site |
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| Placebo | Drug | Participants will receive matching placebo tablets orally. |
|
| Tempe |
| Arizona |
| 85283 |
| United States |
| Neumora Investigator Site | Costa Mesa | California | 92626 | United States |
| Neumora Investigator Site | Lomita | California | 90717 | United States |
| Neumora Investigator Site | Walnut Creek | California | 94596 | United States |
| Neumora Investigator Site | Bradenton | Florida | 34205 | United States |
| Neumora Investigator Site | Greenacres City | Florida | 33467 | United States |
| Neumora Investigator Site | Hallandale | Florida | 33009 | United States |
| Neumora Investigator Site | Hialeah | Florida | 33016 | United States |
| Neumora Investigator Site | Miami | Florida | 33126 | United States |
| Neumora Investigator Site | Miami | Florida | 33137 | United States |
| Neumora Investigator Site | Miami | Florida | 33155 | United States |
| Neumora Investigator Site | Miami Springs | Florida | 33166 | United States |
| Neumora Investigator Site | Orlando | Florida | 32807 | United States |
| Neumora Investigator Site | Pembroke Pines | Florida | 33024 | United States |
| Neumora Investigator Site | Port Orange | Florida | 32127 | United States |
| Neumora Investigator Site | Atlanta | Georgia | 30318 | United States |
| Neumora Investigator Site | Honolulu | Hawaii | 96817 | United States |
| Neumora Investigator Site | Boise | Idaho | 83704 | United States |
| Neumora Investigator Site | Belmont | Massachusetts | 02478 | United States |
| Neumora Investigator Site | Troy | Michigan | 48085 | United States |
| Neumora Investigator Site | Toms River | New Jersey | 08755 | United States |
| Neumora Investigator Site | Brooklyn | New York | 11229 | United States |
| Neumora Investigator Site | East Syracuse | New York | 13057 | United States |
| Neumora Investigator Site | Charlotte | North Carolina | 28204 | United States |
| Neumora Investigator Site | Mesquite | Texas | 75149 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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