Alzheimer's DiseasePhase 1NCT06546995
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 1 study testing NMRA-323511 in people with Alzheimer's Disease and Healthy Elderly, run by Neumora Therapeutics, Inc. at 26 sites in United States.
Trial 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 (PK) of NMRA-323511 among healthy elderly. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy Elderly
- What is being tested?
- NMRA-323511
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 26 sitesUnited States
- Study dates
- 9 Jul 2024to 19 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Neumora Investigator Site
Atlanta, Georgia, 30318
Neumora Investigator Site
Belmont, Massachusetts, 02478
Neumora Investigator Site
Boise, Idaho, 83704
Neumora Investigator Site
Bradenton, Florida, 34205
Neumora Investigator Site
Brooklyn, New York, 11229
Neumora Investigator Site
Chandler, Arizona, 85286
Neumora Investigator Site
Charlotte, North Carolina, 28204
Neumora Investigator Site
Costa Mesa, California, 92626
Neumora Investigator Site
East Syracuse, New York, 13057
Neumora Investigator Site
Greenacres City, Florida, 33467
Neumora Investigator Site
Hallandale, Florida, 33009
Neumora Investigator Site
Hialeah, Florida, 33016
Neumora Investigator Site
Honolulu, Hawaii, 96817
Neumora Investigator Site
Lomita, California, 90717
Neumora Investigator Site
Mesquite, Texas, 75149
Neumora Investigator Site
Miami, Florida, 33126
Neumora Investigator Site
Miami, Florida, 33137
Neumora Investigator Site
Miami, Florida, 33155
Neumora Investigator Site
Miami Springs, Florida, 33166
Neumora Investigator Site
Orlando, Florida, 32807
Neumora Investigator Site
Pembroke Pines, Florida, 33024
Neumora Investigator Site
Port Orange, Florida, 32127
Neumora Investigator Site
Tempe, Arizona, 85283
Neumora Investigator Site
Toms River, New Jersey, 08755
Neumora Investigator Site
Troy, Michigan, 48085
Neumora Investigator Site
Walnut Creek, California, 94596
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Alzheimer's Disease, Healthy Elderly
- Being tested
- NMRA-323511, Placebo
- Keywords
- Alzheimer's Disease, Agitation Associated Dementia, NMRA-323511
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMRA-323511Drug
Participants will receive NMRA-323511 orally.
PlaceboDrug
Participants will receive matching placebo tablets orally.
| Study group | Role | What they receive |
|---|---|---|
| Part A: NMRA-323511 | Experimental | Not described Receives: Drug: NMRA-323511 |
| Part A: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B: NMRA-323511 | Experimental | Not described Receives: Drug: NMRA-323511 |
| Part B: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and Columbia Suicide Severity Rating Scale (C-SSRS) scores will be reported as TEAEs.
Measured: Up to 53 days
Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as a TEAE. Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and C-SSRS scores will be reported as TEAEs.
Measured: Up to Week 10
Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score
The CMAI is a 29-item scale to assess the frequency of agitated behaviors. The 29 agitated behaviors are categorized into agitation factors, including aggressive behavior, physically non-aggressive behavior, and verbally agitated behavior. Each item is rated over the past 2 weeks on a 7-point scale ranging from "Never" (score of 1) to "Several times per hour" (score of 7). The CMAI total score is calculated as the sum of all 29 items and range from 29 (no agitation) to 203 (most severe agitation). A score >45 is commonly regarded as clinically significant agitation.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start9 Jul 2024
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neumora Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546995
- Sponsor's protocol ID
- NMRA-323511-104
- Status last verified
- Nov 2026
- First submitted
- 6 Aug 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06546995
- Acronym / sponsor ID
- NMRA-323511-104
- Conditions
- Alzheimer's Disease, Healthy Elderly
- Keywords
- Alzheimer's Disease, Agitation Associated Dementia, NMRA-323511
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Neumora Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: NMRA-323511 | Experimental | Drug: NMRA-323511 |
| Part A: Placebo | Placebo comparator | Drug: Placebo |
| Part B: NMRA-323511 | Experimental | Drug: NMRA-323511 |
| Part B: Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMRA-323511Participants will receive NMRA-323511 orally. | Drug | Part A: NMRA-323511, Part B: NMRA-323511 |
| PlaceboParticipants will receive matching placebo tablets orally. | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales
Time frame: Up to 53 days
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and Columbia Suicide Severity Rating Scale (C-SSRS) scores will be reported as TEAEs.
Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales
Time frame: Up to Week 10
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as a TEAE. Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and C-SSRS scores will be reported as TEAEs.
Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score
Time frame: Baseline to Week 8
The CMAI is a 29-item scale to assess the frequency of agitated behaviors. The 29 agitated behaviors are categorized into agitation factors, including aggressive behavior, physically non-aggressive behavior, and verbally agitated behavior. Each item is rated over the past 2 weeks on a 7-point scale ranging from "Never" (score of 1) to "Several times per hour" (score of 7). The CMAI total score is calculated as the sum of all 29 items and range from 29 (no agitation) to 203 (most severe agitation). A score >45 is commonly regarded as clinically significant agitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NMRA-323511 in people with Alzheimer's Disease and Healthy Elderly, run by Neumora Therapeutics, Inc. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales (time frame: Up to 53 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.