Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease

Phase 1

Recruiting

• Conditions: Healthy Elderly; Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: NMRA-323511

• Registration Number: NCT06546995
• Lead Sponsor: Neumora Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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 Aging-Alzheimer's Association criteria at least 12 months prior to screening
• Agitation meets the International Psychogeriatric Association (IPA) consensus definition
• Mini-Mental State Examination (MMSE) score = 5 - 24 (mild to severe dementia) at screening

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Exclusion Criteria

Part A

• Participant is actively suicidal
• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
• Diagnosis of epilepsy taking anticonvulsants for seizure control, history of seizures

Part B

• Dementia or memory impairment due to a reason other than AD
• Clinically significant neurologic disorder other than AD
• Have any clinically significant and uncontrolled medical condition

Note: Other protocol defined inclusion/exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: Placebo	Placebo	-
Part A: NMRA-323511	NMRA-323511	-
Part B: NMRA-323511	NMRA-323511	-
Part B: Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales	Up to 53 days	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.
Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score	Baseline to Week 8	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.
Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales	Up to Week 10	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.

Trial Locations

Locations (1)

Neumora Investigator Site; 🇺🇸 Mesquite, Texas, United States