Investigator Initiated Trial: Alzheimer’s
Neurodegenerative Diseases
Our goal is to make Alzheimer’s dementia preventable. We will do so with a primary focus in disease modification in Alzheimer’s disease, discovering and selecting therapeutic targets with compelling evidence from human genetics and pathophysiology, and using biomarkers to detect pathology and begin treatment earlier in the disease process where there is the greatest opportunity to prevent memory problems and functional decline from the beginning. We will complement our disease modification efforts through targeted pursuit of transformative therapies for cognitive and psychiatric symptoms.
NOTE :Please be aware that only requests for use in locations where donanemab has been approved for marketing for at least one indication and is commercially available where the research is being conducted will be considered for research support.
Dona research requests must be innovative and demonstrate the ability to enhance and/or expand scientific knowledge for use in clinical practice.
Research Areas of Interest
- Preference will be given to studies which:
- a. provide better understanding of the clinical utility and/or health economic perspective of donanemab in subjects not fully represented in past or current trials (e.g., under-represented minorities, medical or neurological co-morbidities, atypical clinical syndromes).
- b. inform potential biomarkers for patient selection and/or predicting response to donanemab.
- c. help understand clinicopathologic/genomic features associated with responders and non-responders to donanemab.
- d. investigate approaches to further improve clinical outcomes (efficacy and/or safety) with donanemab.
- e. explore novel measures to monitor donanemab efficacy in clinical practice.
Out of Scope
- Research questions and therapeutic indications involving the assessment of donanemab that either have been previously investigated, and/or currently under investigation in ongoing clinical development by Lilly (including preclinical AD)
- Use of donanemab in combination with other ATTs
- AD natural history and/or pathophysiology studies
- Pediatric use
- Alternative delivery systems/modes
- Investigation of donanemab in animal studies
PIRA™ proposals are AI generated and are not reviewed or endorsed by the sponsoring company.