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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Phase 1b, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease

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

Condition
Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Tempe

Neumora Investigator Site, Tempe, Arizona, United States, 85283

Costa Mesa

Neumora Investigator Site, Costa Mesa, California, United States, 92626

Walnut Creek

Neumora Investigator Site, Walnut Creek, California, United States, 94596

Toms River

Neumora Investigator Site, Toms River, New Jersey, United States, 08755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

55 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Neumora Therapeutics, Inc.,

Study Record Dates

2025-11