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

Neumora Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Alzheimer's Disease; Healthy Elderly

Treatments: Drug: Placebo; Drug: NMRA-323511

Study type: Interventional

Funder types: Industry

Identifiers

NCT06546995

NMRA-323511-104

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 4 patient groups, including a placebo group

Part A: NMRA-323511

Experimental group

Treatment:

Drug: NMRA-323511

Part A: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Part B: NMRA-323511

Experimental group

Treatment:

Drug: NMRA-323511

Part B: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo