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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Alzheimer's Disease
Location: United States, FL

Clinical Trial Details

Overview

Research Study Summary

A Phase 2 Multiple Dose, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Subjects With Early Alzheimer's Disease

Purpose
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.
To Learn more

CW ID: 222939
Date Last Changed: February 6, 2017

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
55 to 85 Years
Overall Status
Recruiting
Lead Sponsor
AbbVie
Facility Type
N/A

Eligibility

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 to 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.

Contact

Jill Smith
University of South Florida - USF Health Byrd Alzheimer's Institute
4001 Fletcher Ave
Tampa, FL 33613
Phone: (813) 974-1294

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