Status:
COMPLETED
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
Lead Sponsor:
Neumora Therapeutics, Inc.
Conditions:
Alzheimer's Disease
Healthy Elderly
Eligibility:
All Genders
55-90 years
Phase:
PHASE1
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 (P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06546995
Start Date
July 9 2024
End Date
November 19 2025
Last Update
November 21 2025
Active Locations (26)
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1
Neumora Investigator Site
Chandler, Arizona, United States, 85286
2
Neumora Investigator Site
Tempe, Arizona, United States, 85283
3
Neumora Investigator Site
Costa Mesa, California, United States, 92626
4
Neumora Investigator Site
Lomita, California, United States, 90717