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CTAD 2022 | The Phase III NILEAD trial: nilotinib as a novel treatment for AD

Charbel Moussa, MBBS, PhD, Georgetown University Medical Center, Washington, D.C. gives an insight to the prospective Phase III, multicenter, placebo-controlled NILEAD trial, investigating the use of nilotinib BE (bioequivalent) to treat Alzheimer’s disease (AD). The trial will include patients in the early stages of AD who have a MMSE score of between 20-27 and a CDR of 0.5-1. Approximately 1275 patients will be randomized to receive placebo or nilotinib BE at a low or high dose. The primary endpoint will be the change in the Clinical Dementia Rating–Sum of Boxes (CDR-SB) from baseline to 18 months. Biomarker and imaging sub-studies will assess the longitudinal impact of nilotinib BE on various cerebrospinal fluid and imaging measures. Researchers also plan to investigate the added effect of nilotinib to anti-amyloid therapies. Nilotinib has been shown to reduce amyloid beta, facilitate autophagy, protect the blood-brain barrier, and lower inflammation. If lecanemab is approved in the coming months, all patients enrolled will be treated with lecanemab as the standard of care to test this combination. This interview took place at the Clinical Trials on Alzheimer’s Disease congress 2022 in San Francisco.

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