RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-07-09
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06546995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy participants
  2. * Age 65 to 80 years
  3. * Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 at the screening and check-in visit
  4. * Participants aged 55 to 90 years
  5. * 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
  6. * Agitation meets the International Psychogeriatric Association (IPA) consensus definition
  7. * Mini-Mental State Examination (MMSE) score = 5 - 24 (mild to severe dementia) at screening
  1. * Participant is actively suicidal
  2. * Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
  3. * Diagnosis of epilepsy taking anticonvulsants for seizure control, history of seizures
  4. * Dementia or memory impairment due to a reason other than AD
  5. * Clinically significant neurologic disorder other than AD
  6. * Have any clinically significant and uncontrolled medical condition

Contacts and Locations

Study Contact

Study Contact
CONTACT
clinicaltrials@neumoratx.com

Study Locations (Sites)

Neumora Investigator Site
Tempe, Arizona, 85283
United States
Neumora Investigator Site
Costa Mesa, California, 92626
United States
Neumora Investigator Site
Walnut Creek, California, 94596
United States
Neumora Investigator Site
Toms River, New Jersey, 08755
United States

Collaborators and Investigators

Sponsor: Neumora Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-09
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-07-09
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's Disease
  • Agitation Associated Dementia
  • NMRA-323511

Additional Relevant MeSH Terms

  • Alzheimer's Disease
  • Healthy Elderly