NCT06546995CompletedPhase 1
Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 6 Aug 2024
- Start date
- 9 Jul 2024
- Primary completion date
- 19 Nov 2025
- Lead sponsor
- Neumora Therapeutics, Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT06546995
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 87
- From 9 Jul 2024 to the primary completion date, 19 Nov 2025
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Part A
- Participant is actively suicidal
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
Who the study is looking for
- 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
Age in the registry: 55 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.