Vanderbilt Clinical Trials

A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

Purpose

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).

Condition

Alzheimer's Disease

Eligibility

Eligible Ages: Between 55 Years and 85 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have: - Clinical Dementia Rating (CDR)-Global Score of 0.5 - Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive - Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower - Subject has a positive amyloid positron emission tomography (PET) scan. - Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4. - The subject has an identified, reliable, study partner (e.g., family member). - If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

Exclusion Criteria

Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture. - Subject has evidence of any other clinically significant neurological disorder other than early AD. - In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days. - Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator Placebo	Placebo for ABBV-8E12 every 4 weeks for 96 weeks	Drug: placebo for ABBV-8E12 placebo solution for intravenous (IV) infusion
Experimental ABBV-8E12 300 mg	ABBV-8E12 300 mg every 4 weeks for 96 weeks	Drug: ABBV-8E12 ABBV-8E12 solution for IV infusion Other names: Tilavonemab
Experimental ABBV-8E12 1000 mg	ABBV-8E12 1000 mg every 4 weeks for 96 weeks	Drug: ABBV-8E12 ABBV-8E12 solution for IV infusion Other names: Tilavonemab
Experimental ABBV-8E12 2000 mg	ABBV-8E12 2000 mg every 4 weeks for 96 weeks	Drug: ABBV-8E12 ABBV-8E12 solution for IV infusion Other names: Tilavonemab

More Details

Status: Completed
Sponsor: AbbVie

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.