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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT02880956

Run by

AbbVie

People needed

453

Starts

2017-01-26

Expected to finish

2021-07-28

Last updated by the study team

2022-08-26

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner Sun Health Res Inst /ID# 151895 — Sun City, Arizona, United States
• Irvine Clinical Research /ID# 162331 — Irvine, California, United States
• Ucsd /Id# 152467 — La Jolla, California, United States
• Ray Dolby Brain Health Center /ID# 154965 — San Francisco, California, United States
• Univ California, San Francisco /ID# 152053 — San Francisco, California, United States
• Brain Matters Research /ID# 147796 — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida /ID# 162332 — Fort Myers, Florida, United States
• Mayo Clinic /ID# 151236 — Jacksonville, Florida, United States
• Synexus Clinical Research US, Inc. /ID# 147804 — Orlando, Florida, United States
• University of South Florida /ID# 151890 — Tampa, Florida, United States
• Synexus Clinical Research US, Inc /ID# 151633 — The Villages, Florida, United States
• Emory Midtown Infectious Disease Clinic /ID# 151492 — Atlanta, Georgia, United States
• Atlanta Center for Medical Research /ID# 151550 — Atlanta, Georgia, United States
• NeuroStudies.net, LLC /ID# 152746 — Decatur, Georgia, United States
• Great Lakes Clinical Trials /ID# 152754 — Chicago, Illinois, United States
• Advocate Lutheran General Hospital /ID# 152052 — Park Ridge, Illinois, United States
• Southern IL Univ School of Med /ID# 151769 — Springfield, Illinois, United States
• Indiana University /ID# 151861 — Indianapolis, Indiana, United States
• University of Kansas Medical Center - Alzheimer's Disease Center /ID# 151554 — Fairway, Kansas, United States
• University of Kentucky Chandler Medical Center /ID# 152753 — Lexington, Kentucky, United States
• Johns Hopkins Bayview Med Cnt /ID# 151893 — Baltimore, Maryland, United States
• Massachusetts General Hospital /ID# 151770 — Boston, Massachusetts, United States
• Brigham and Women's Physicians /ID# 151882 — Boston, Massachusetts, United States
• Hattiesburg Clinic /ID# 202388 — Hattiesburg, Mississippi, United States
• Banner University of Arizona Medical Center Phoenix /ID# 151536 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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