Abstract Details

Title HARBOR: ABBV-916 In Subjects With Early Alzheimer’s Disease Combined Multiple-Ascending Dose/Proof-Of-Concept Study Design

Topic Aging, Dementia, and Behavioral Neurology

Presentation(s) P7 - Poster Session 7 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-008

Objective This study evaluates safety, tolerability, pharmacokinetics, immunogenicity, and amyloid reduction associated with ABBV-916, a recombinant humanized immunoglobulin G1 monoclonal antibody, in subjects with early AD.

Background

Alzheimer’s disease (AD) is the most common cause of dementia in the elderly.

Design/Methods Approximately 163 subjects will be enrolled in this Phase 1b/2 multicenter, randomized, placebo-controlled, double-blind, dose-finding study (NCT05291234), which consists of 2 stages: multiple-ascending dose (MAD; Phase 1b; Stage A) and proof-of-concept (POC; Phase 2; Stage B). Each stage has a 60-day screening period, 24-week double-blind period (ABBV-916 or placebo administered intravenously once every 4 weeks) and a 16-week safety follow-up period, with the option of a 2-year open-label extension. Subjects must meet the following inclusion criteria: be between 50 and 90 years of age, diagnosis of Stage 3 or 4 AD, as defined by the 2018 NIA-AA Research Framework, a Mini-Mental State Examination score between 20 and 28, a positive Precivity AD-Aβ blood test, and an amyloid PET scan consistent with amyloid pathology.

Results Safety evaluations include adverse events reports, clinical laboratory tests, MRI, vital signs, electrocardiograms, and the Columbia-Suicide Severity Rating Scale. Cerebrospinal fluid collection is required for subjects in Stage A and optional for subjects in Stage B. Change from baseline in brain amyloid plaque deposition is measured by amyloid PET scan in Stage B.

Conclusions This study tests the hypothesis that ABBV-916 will lead to rapid and robust removal of amyloid plaques from the brain of subjects with AD.

Authors/Disclosures
Sagar S. Bachhav, PhD (Abbvie Inc.) PRESENTER	Dr. Bachhav has received personal compensation for serving as an employee of AbbVie Inc, USA. Dr. Bachhav has stock in AbbVie Inc. USA.
	No disclosure on file
Shau Yu Lynch (AbbVie)	Shau Yu Lynch has received personal compensation for serving as an employee of AbbVie. Shau Yu Lynch has received personal compensation for serving as an employee of Eisai. Shau Yu Lynch has stock in AbbVie.
Hana Florian	Hana Florian has received personal compensation for serving as an employee of AbbVie. Hana Florian has stock in AbbVie.
Deli Wang, MD, PhD (AbbVie Inc.)	Dr. Wang has received personal compensation for serving as an employee of AbbVie Inc.. Dr. Wang has stock in AbbVie Inc..
Joey C. Boiser, MD (AbbVie)	Dr. Boiser has received personal compensation for serving as an employee of AbbVie. Dr. Boiser has stock in AbbVie.
	No disclosure on file
	No disclosure on file
Ole Graff, MD	Dr. Graff has received personal compensation for serving as an employee of AbbVie. Dr. Graff has stock in AbbVie.

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