Clinical trial NCT06546995: Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Alzheimer's Disease
Healthy Elderly
Keywords: Alzheimer's Disease
Agitation Associated Dementia
NMRA-323511
Lead sponsor: Neumora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 96
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.


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

Primary outcomes:
measure: Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales
timeFrame: Up to 53 days
measure: Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales
timeFrame: Up to Week 10
measure: Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Neumora Investigator Site
state: Arizona
city: Tempe
country: United States
facility: Neumora Investigator Site
state: Arizona
city: Costa Mesa
country: United States
facility: Neumora Investigator Site
state: California
city: Lomita
country: United States
facility: Neumora Investigator Site
state: California
city: Walnut Creek
country: United States
facility: Neumora Investigator Site
state: California
city: Bradenton
country: United States
facility: Neumora Investigator Site
state: Florida
city: Greenacres City
country: United States
facility: Neumora Investigator Site
state: Florida
city: Hallandale Beach
country: United States
facility: Neumora Investigator Site
state: Florida
city: Hialeah
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami Springs
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Miami
country: United States
facility: Neumora Investigator Site
state: Florida
city: Orlando
country: United States
facility: Neumora Investigator Site
state: Florida
city: Pembroke Pines
country: United States
facility: Neumora Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Neumora Investigator Site
state: Georgia
city: Honolulu
country: United States
facility: Neumora Investigator Site
state: Hawaii
city: Boise
country: United States
facility: Neumora Investigator Site
state: Idaho
city: Belmont
country: United States
facility: Neumora Investigator Site
state: Massachusetts
city: Troy
country: United States
facility: Neumora Investigator Site
state: Michigan
city: Toms River
country: United States
facility: Neumora Investigator Site
state: New Jersey
city: Brooklyn
country: United States
facility: Neumora Investigator Site
state: New York
city: East Syracuse
country: United States
facility: Neumora Investigator Site
state: New York
city: Charlotte
country: United States
facility: Neumora Investigator Site
state: North Carolina
city: Mesquite
country: United States
facility: Neumora Investigator Site
state: Texas
Study officials:
References: