Abstract Details

Title Baseline EMBARK Data From EMERGE, ENGAGE, and PRIME Participants in the EMBARK Redosing Study

Topic Aging and Dementia

Presentation(s) N1 - Neuroscience in the Clinic: Aducanumab: From Clinical Trials to the Clinic (3:20 PM-3:30 PM)

Poster/Presentation
Number 002

Background

Aducanumab is a human monoclonal antibody targeting soluble and insoluble amyloid beta (Aβ) aggregates. Aducanumab was approved for the treatment of mild cognitive impairment due to Alzheimer’s disease or mild dementia due to Alzheimer’s disease by the US Food and Drug Administration under the accelerated approval pathway. This approval was based on the reduction in Aβ plaques observed in treated patients.

Objective

To describe demographic and baseline clinical characteristics, evaluate amyloid positron emission tomography (PET) biomarker levels, and analyze the effect of amyloid clearance on clinical measures following the off-treatment gap preceding the EMBARK study (NCT04241068) in participants formerly enrolled in EMERGE (n=902; NCT02484547), ENGAGE (n=868; NCT02477800), or PRIME (n=29; NCT01677572).

Design/Methods

EMBARK is an open-label study assessing the long-term safety and efficacy of aducanumab 10 mg/kg (the marketed dose) over 24 months in participants with Alzheimer’s disease who were enrolled in aducanumab clinical trials (PRIME/EVOLVE/EMERGE/ENGAGE) when the studies were discontinued (March 21, 2019).

Results

A total of 902 participants from EMERGE, 868 from ENGAGE, and 29 from PRIME entered EMBARK. In the subset of EMERGE and ENGAGE participants who were evaluated by longitudinal amyloid PET, reductions in amyloid PET composite standardized uptake value ratio (SUVR) observed in aducanumab-treated groups at the final PET scan persisted during the treatment gap period (~1.7 years) leading up to EMBARK’s baseline.

Analysis of change in clinical measures from baseline in EMERGE/ENGAGE/PRIME stratified by amyloid PET composite SUVR (>1.10 or ≤1.10) at the last EMERGE/ENGAGE/PRIME study visit will also be presented for the subset of participants with longitudinal amyloid PET data

Conclusions

Aβ plaque reduction achieved with aducanumab treatment persisted during the treatment gap, suggesting a prolonged effect on Aβ plaque levels. Whether and to what extent this reduction may be maintained with a longer interruption of aducanumab treatment remain unclear.

Authors/Disclosures
Sharon Cohen, MD PRESENTER	The institution of Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alnylam. The institution of Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Cohen has received personal compensation in the range of $0-$499 for serving as a Consultant for Diamond Therapeutics Inc.. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ProMIS Neurosciences Inc.. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for RetiSpec Inc.. The institution of Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for College of Physicians and Surgeons of Ontario. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CME Outfitters. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Integritas. The institution of Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DBK Med.
Christopher van Dyck, MD (Yale School of Medicine)	Christopher van Dyck, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ono. Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. Christopher van Dyck, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. An immediate family member of Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supurnus. An immediate family member of Christopher van Dyck, MD has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Polaris Management Partners. The institution of Christopher van Dyck, MD has received research support from Roche/Genentech. The institution of Christopher van Dyck, MD has received research support from Eli Lilly. The institution of Christopher van Dyck, MD has received research support from Biogen. The institution of Christopher van Dyck, MD has received research support from Biohaven. The institution of Christopher van Dyck, MD has received research support from Eisai. The institution of Christopher van Dyck, MD has received research support from UCB. The institution of Christopher van Dyck, MD has received research support from Cerevel. The institution of Christopher van Dyck, MD has received research support from Janssen.
	No disclosure on file
Anton P. Porsteinsson, MD (AD-CARE - University of Rochester School of Medicine)	Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ONO Pharmaceuticals. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Porsteinsson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Porsteinsson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for WebMD. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Otsuka. Dr. Porsteinsson has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acadia. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Functional Neuromodulation. Dr. Porsteinsson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon Pharmaceuticals. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Porsteinsson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cognitive Research Corporation. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Athira. Dr. Porsteinsson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. The institution of Dr. Porsteinsson has received research support from Alector. The institution of Dr. Porsteinsson has received research support from Eisai. The institution of Dr. Porsteinsson has received research support from Eli Lilly. The institution of Dr. Porsteinsson has received research support from Athira. The institution of Dr. Porsteinsson has received research support from Genentech/Roche. The institution of Dr. Porsteinsson has received research support from Cassava. The institution of Dr. Porsteinsson has received research support from Vaccinex.
	No disclosure on file
	No disclosure on file
Annie Racine, PhD (Alexion)	Annie Racine has received personal compensation for serving as an employee of Biogen. Annie Racine has received stock or an ownership interest from Biogen.
	No disclosure on file
Samantha Budd Haeberlein	Samantha Budd Haeberlein has received personal compensation for serving as an employee of Biogen. An immediate family member of Samantha Budd Haeberlein has received personal compensation for serving as an employee of Alkermes. Samantha Budd Haeberlein has received stock or an ownership interest from Biogen.
Stephen P. Salloway, MD, MS (Brown Medical School)	Dr. Salloway has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Salloway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EISAI. Dr. Salloway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lilly. Dr. Salloway has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Salloway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NovoNordisk. Dr. Salloway has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Prothena. Dr. Salloway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amylyx. Dr. Salloway has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Salloway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ono. Dr. Salloway has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bolden. Dr. Salloway has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EISAI. Dr. Salloway has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acumen. Dr. Salloway has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly.