Results from the long-term extension of PRIME: A randomized Phase 1b trial of aducanumab.

Tianle ChenJohn O'GormanCarmen Castrillo-VigueraRajasimhan RajagovindanGioacchino G CurialeYing TianDakshaben PatelPhilipp von RosenstielChristian von HehnStephen SallowayChristoph HockRoger M NitschSamantha Budd HaeberleinAlfred SandrockPriya Singhal

Published in: Alzheimer's & dementia : the journal of the Alzheimer's Association (2024)

PRIME was a Phase 1b, double-blind, randomized clinical trial of aducanumab. We report cumulative safety and 48-month efficacy results from PRIME. Amyloid-related imaging abnormalities-edema (ARIA-E) were the most common adverse event (AE); 61% of participants with ARIA-E were asymptomatic. Dose titration was associated with a decrease in the incidence of ARIA-E. Aducanumab decreased levels of amyloid beta (Aβ) in a dose- and time-dependent manner.

Keyphrases

double blind
phase iii
clinical trial
study protocol
phase ii
placebo controlled
risk factors
open label
emergency department
mass spectrometry
drug induced