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

NCT06546995

CompletedPhase 1

Sponsor: Neumora Therapeutics, Inc.

Conditions: Alzheimer's Disease, Healthy Elderly

Interventions: NMRA-323511, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (26)

Chandler, Arizona, United States
Tempe, Arizona, United States
Costa Mesa, California, United States
Lomita, California, United States
Walnut Creek, California, United States
Bradenton, Florida, United States
Greenacres City, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Springs, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Belmont, Massachusetts, United States
Troy, Michigan, United States
Toms River, New Jersey, United States
Brooklyn, New York, United States
East Syracuse, New York, United States
Charlotte, North Carolina, United States
Mesquite, Texas, United States