A study of NanoLithium® NP03 in mild-to-severe Alzheimer's Disease patients
The research company Medesis Pharma SA is conducting the clinical trial Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease (NanoLi®_AD).
This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).
It is planned to include 68 participants.
Actual study start date is May 20, 2022. The researchers expect to complete the study by February 2024.
One primary outcome measure is NPI-12 total score, The change from baseline to end of double-blind period (W12) of the NPI-12 total score in the NanoLithium® NP03 arm and in the placebo arm.
Further details can be found here https://ichgcp.net/clinical-trials-registry/NCT05423522 or https://clinicaltrials.gov/ct2/show/NCT05423522.
