CompletedPhase 1

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

United States96 participantsStarted 2024-07-09

Plain-language 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.

Who can participate

Age range55 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

What they're measuring

Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales

Timeframe: Up to 53 days

Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales

Timeframe: Up to Week 10

Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT06546995

SponsorNeumora Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-19

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