Alzheimer's Disease Research Study
Researchers at McLean Hospital are conducting a clinical research study for those with agitation associated with dementia due to Alzheimer’s disease.
Fast Facts
Ages 55-90 with Alzheimer's Disease (Diagnosed for at Least 12 months)
Experiencing Agitation for At Least 2 Weeks
Compensation Provided
Conducted in Belmont, MA
Study Background
This study is being conducted to evaluate the safety and effectiveness of an investigational drug (NMRA-323511) for treating agitation in individuals with Alzheimer’s disease (AD) or Alzheimer’s clinical syndrome.
Agitation is a common and distressing symptom of AD that can significantly impact patients and their caregivers, often requiring medical intervention. Current treatment options are limited, and better pharmacological solutions are needed to manage agitation in this population. By participating in this study, researchers aim to determine whether the investigational drug can help reduce agitation symptoms while maintaining safety and tolerability.
We hope that eventually, the findings from this study may contribute to the development of new treatment options that improve the quality of life for individuals living with AD and their caregivers.
Study Background
This study is being conducted to evaluate the safety and effectiveness of an investigational drug (NMRA-323511) for treating agitation in individuals with Alzheimer’s disease (AD) or Alzheimer’s clinical syndrome.
Agitation is a common and distressing symptom of AD that can significantly impact patients and their caregivers, often requiring medical intervention. Current treatment options are limited, and better pharmacological solutions are needed to manage agitation in this population. By participating in this study, researchers aim to determine whether the investigational drug can help reduce agitation symptoms while maintaining safety and tolerability.
We hope that eventually, the findings from this study may contribute to the development of new treatment options that improve the quality of life for individuals living with AD and their caregivers.
Additional Information
The NMRA-323511-104 Study will test how effective, tolerable (meaning how well study participants cope with any side effects), and safe a study medication may be in people experiencing agitation related to Alzheimer’s disease. Our eventual goal is to develop new treatment strategies to improve the lives of individuals with AD as well as their caregivers.
You or someone you are caring for may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 55-90
- Diagnosis of Alzheimer’s Disease or Alzheimer’s clinical syndrome (for at least 12 months)
- Experiencing agitation, including feeling tense and restless, for at least 2 weeks
- Have a caregiver who spends at least 2 hours per day, 4 days per week with you and can accompany you to study visits
- BMI of 18 to 35 kg/m²
Exclusion Criteria:
- Diagnosis of dementia other than AD (e.g., vascular dementia, Lewy body dementia, Parkinson’s disease dementia)
- History of seizures, serious head injury, or intracranial neoplasm/hemorrhage
- Severe psychiatric disorders, including schizophrenia, bipolar disorder, or active suicidal intent in the past 6 months
- Uncontrolled medical conditions, such as cardiovascular disease, severe diabetes, or significant liver/kidney dysfunction
- Recent substance or alcohol use disorder within the past 12 months, excluding nicotine
This is an in-person clinical trial involving an investigational drug, NMRA-323511.
Eligible participants will:
- Receive a 20 mg (10mg each, 2 capsules) dose of the study drug twice daily
- Be closely monitored for any potential side effects, including changes in the central nervous system, skin-related reactions, and overall health
- Undergo safety assessments including physical and neurological exams, ECGs, vital sign measurements, body weight checks, clinical laboratory testing, and regular evaluations using the Columbia Suicide Severity Rating Scale (C-SSRS)
Participants will need to attend scheduled visits at the research site, accompanied by their caregiver, to make sure they are being properly monitored and following the study procedures. If any negative effects occur, there are clear guidelines in place to adjust or stop the study drug as necessary. Participants will need to follow specific medication guidelines and will be required to temporarily stop taking certain medications that may interfere with the study.
Participants will be compensated up to $807.50.
There is no cost to participate in our research study.
