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

NCT06546995 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NMRA-323511-104
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 26

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.

Conditions

Alzheimer's Disease; Healthy Elderly

Keywords

Alzheimer's Disease; Agitation Associated Dementia; NMRA-323511

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Part A: NMRA-323511

EXPERIMENTAL

Drug: NMRA-323511

Part A: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Part B: NMRA-323511

EXPERIMENTAL

Drug: NMRA-323511

Part B: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NMRA-323511 DRUG

Participants will receive NMRA-323511 orally.

Part A: NMRA-323511; Part B: NMRA-323511

Placebo DRUG

Participants will receive matching placebo tablets orally.

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neumora Therapeutics, Inc.: lead

Study Sites (26)

Neumora Investigator Site

Chandler, Arizona, 85286, United States

Location

Neumora Investigator Site

Tempe, Arizona, 85283, United States

Location

Neumora Investigator Site

Costa Mesa, California, 92626, United States

Location

Neumora Investigator Site

Lomita, California, 90717, United States

Location

Neumora Investigator Site

Walnut Creek, California, 94596, United States

Location

Neumora Investigator Site

Bradenton, Florida, 34205, United States

Location

Neumora Investigator Site

Greenacres City, Florida, 33467, United States

Location

Neumora Investigator Site

Hallandale, Florida, 33009, United States

Location

Neumora Investigator Site

Hialeah, Florida, 33016, United States

Location

Neumora Investigator Site

Miami, Florida, 33126, United States

Location

Neumora Investigator Site

Miami, Florida, 33137, United States

Location

Neumora Investigator Site

Miami, Florida, 33155, United States

Location

Neumora Investigator Site

Miami Springs, Florida, 33166, United States

Location

Neumora Investigator Site

Orlando, Florida, 32807, United States

Location

Neumora Investigator Site

Pembroke Pines, Florida, 33024, United States

Location

Neumora Investigator Site

Port Orange, Florida, 32127, United States

Location

Neumora Investigator Site

Atlanta, Georgia, 30318, United States

Location

Neumora Investigator Site

Honolulu, Hawaii, 96817, United States

Location

Neumora Investigator Site

Boise, Idaho, 83704, United States

Location

Neumora Investigator Site

Belmont, Massachusetts, 02478, United States

Location

Neumora Investigator Site

Troy, Michigan, 48085, United States

Location

Neumora Investigator Site

Toms River, New Jersey, 08755, United States

Location

Neumora Investigator Site

Brooklyn, New York, 11229, United States

Location

Neumora Investigator Site

East Syracuse, New York, 13057, United States

Location

Neumora Investigator Site

Charlotte, North Carolina, 28204, United States

Location

Neumora Investigator Site

Mesquite, Texas, 75149, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: July 9, 2024
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)