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 Alzheimer’s disease and other dementias produce changes in multiple domains including cognition, function and behavior. Each of these domains may respond to treatment and should be measured as a trial outcome. Measuring behavior in your trial may provide critically important outcome data useful in understanding and explaining the value of treatment. The NPI is the behavior instrument most widely used in clinical trials of antidementia agents.
- The Food and Drug Administration (FDA) division of Neurology Products and the Division of Psychiatry Products are familiar with the NPI.
- Neuropsychiatric disturbances are among the most burdensome to caregivers and are a management challenge to clinicians. Reducing behavioral changes or delaying their emergence is a an important value for an agent use to treat patients with Alzheimer's disease or other dementia. When documented in trials this property has commercial importance.
- The NPI-Q is collected in the Alzheimer's Disease Neuroimaging Initiative (ADNI) and is part of the national database of the National Alzheimer's Coordinating Center (NACC) sponsored by the National Institute on Aging (NIA)
- The NPI assesses a wide range (10 or 12 determined by the NPI version chosen) of behaviors common in dementia syndromes.
- The NPI has an integrated caregiver distress measure to demonstrate the secondary effect of treatment on caregivers.
- The NPI has known measurement products including rate of change annually, relationship to cognitive, global and functional measures, standard deviations, and requirements for sample size determinations.
- A variety of analytic approaches to NPI data have been developed including analysis of patients symptomatic at baseline to determine if the agent ameliorates behavioral changes and analysis of patients without symptoms are baseline to determine if the study agent reduces the emergence of new behaviors in the course of the trial.
- Groups of NPI symptoms can be used in trials to determine the effect of treatment on psychosis (delusions plus hallucinations).
- Most trial sites are familiar with the NPI.
- NPI training materials are available and senior investigators can provide training in investigator meetings.
- Translations of the NPI are available in many languages for use in global trials.
- The NPI is available on this site after agreement to payment
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