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

Launched by NEUMORA THERAPEUTICS, INC. · Aug 6, 2024

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ClinConnect Summary

This clinical trial is studying a new medication called NMRA-323511 to see how safe and effective it is for two different groups of people: healthy older adults and adults who have agitation related to Alzheimer’s disease. The trial has two parts. In the first part, healthy participants aged 65 to 80 will receive either the medication or a placebo (a look-alike pill with no active ingredients) to help researchers understand how the medication is processed in the body and how well it is tolerated. In the second part, adults aged 55 to 90 who have been diagnosed with Alzheimer’s and experience agitation will be involved to see if the medication can help reduce their symptoms.

To be eligible for the trial, healthy participants need to be between 65 and 80 years old, while those with Alzheimer's must be between 55 and 90 and have specific symptoms of agitation. Participants will first undergo a screening process, followed by a treatment period where they will receive the medication or placebo, and then a follow-up visit. This study aims to gather important information about NMRA-323511 that could lead to better treatments for agitation in Alzheimer’s patients, so if you or someone you know fits the criteria, this could be an opportunity to contribute to important research.

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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