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

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ClinicalTrials.gov Identifier: NCT02880956
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study seeks to evaluate the efficacy and safety of ABBV-8E12 in subjects with Early Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABBV-8E12 Drug: placebo for ABBV-8E12 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 17, 2016
Estimated Primary Completion Date : December 16, 2020
Estimated Study Completion Date : June 29, 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1
Dose 1 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Experimental: Group 3
Dose 3 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 (20 mg/mL) solution for IV infusion
Placebo Comparator: Group 4
Placebo for ABBV-8E12
Drug: placebo for ABBV-8E12
placebo solution for IV infusion


Outcome Measures

Primary Outcome Measures :
  1. Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
    A scale used to quantify the severity of symptoms of dementia.

  2. Adverse Events [ Time Frame: 112 weeks ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  2. Time to Cmax (Tmax) for ABBV-8E12 [ Time Frame: 16 weeks ]
  3. Area under the concentration time curve (AUC) for ABBV-8E12 [ Time Frame: 16 weeks ]
  4. Serum concentration at the end of a dose interval (Ctrough) for ABBV-8E12 [ Time Frame: 96 weeks ]
  5. Mini-Mental State Examination (MMSE) [ Time Frame: 96 weeks ]
    A 30-point questionnaire that provides a quantitative measure of cognitive mental status in adults.

  6. Alzheimer's Disease Assessment Scale (14-Item) Cognition Portion (ADAS-Cog-14) [ Time Frame: 96 weeks ]
    A scale that assesses the cognitive impairments most common in AD.

  7. Repeatable Battery for Assessment of Neuropsychological Status (RBANS) [ Time Frame: 96 weeks ]
    A standardized neurocognitive battery that measures cognitive decline or improvement across five neurocognitive domains.

  8. 24-Item Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for Patients with Mild Cognitive Impairment (ADCS-MCI-ADL-24) [ Time Frame: 96 weeks ]
    A 24-item, study partner-based assessment of activities of daily living designed specifically for AD patients.

  9. Functional Activities Questionnaire (FAQ) [ Time Frame: 96 weeks ]
    A questionnaire used to measure level of assistance (functional disability) needed for carrying out instrumental activities in daily living.

  10. University of California's Performance Based Skills Assessment, Brief Version (UPSA-Brief) [ Time Frame: 96 weeks ]
    A performance-based instrument which uses a series of tasks and role-play scenarios to evaluate a person's functional capacity in two areas of basic living skills (i.e., financial skills and communication skills).

  11. Alzheimer's Disease Cooperative Study Clinical Global Impression of Change for Mild Cognitive Impairment (ADCS-CGIC-MCI). [ Time Frame: 96 weeks ]
    The instrument assesses the physician's global impression of change four major cognitive domains.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880956


Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute /ID# 151536 Recruiting
Phoenix, Arizona, United States, 85006
Contact: William Burke, MD         
Banner Sun Health Research Institute /ID# 151895 Recruiting
Sun City, Arizona, United States, 85351
United States, California
Irvine Clinical Research /ID# 162331 Recruiting
Irvine, California, United States, 92614
UCSD Shiley-Marcos Alzheimer's Disease Research center /ID# 152467 Not yet recruiting
La Jolla, California, United States, 92037-0949
Pacific Research Network, Inc. /ID# 151127 Withdrawn
San Diego, California, United States, 92103
Ray Dolby Brain Health Center/CPMC /ID# 154965 Recruiting
San Francisco, California, United States, 94114
UCSF Memory and Aging Center /ID# 152053 Recruiting
San Francisco, California, United States, 94158
Neurological Research Institute /ID# 152718 Not yet recruiting
Santa Monica, California, United States, 90404
United States, Florida
Parkinson's Disease and Movement Disorder Center /ID# 152759 Not yet recruiting
Boca Raton, Florida, United States, 33486
Brain Matters Research /ID# 147796 Recruiting
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research Center of Southwest Florida /ID# 162332 Recruiting
Fort Myers, Florida, United States, 33912
Mayo Clinic /ID# 151236 Recruiting
Jacksonville, Florida, United States, 32224
Compass Research LLC /ID# 147804 Recruiting
Orlando, Florida, United States, 32806
University of South Florida /ID# 151890 Recruiting
Tampa, Florida, United States, 33613
Compass Research, LLC /ID# 151633 Recruiting
The Villages, Florida, United States, 32162
Contact: David Subich, MD         
United States, Georgia
Emory Brain Health Center /ID# 151492 Recruiting
Atlanta, Georgia, United States, 30322
Contact: James Lah, MD         
Atlanta Center for Medical Research /ID# 151550 Recruiting
Atlanta, Georgia, United States, 30331
Contact: Robert Riesenberg, MD         
NeuroStudies.net, LLC /ID# 152746 Recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Great Lakes Clinical Trials /ID# 152754 Recruiting
Chicago, Illinois, United States, 60640
Contact: John Lavaccare, MD         
Advocate Lutheran General Hospital Advocate Memory Center /ID# 152052 Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Darren Gitelman, MD         
Southern Illinois University School of Medicine /ID# 151769 Recruiting
Springfield, Illinois, United States, 62702
Contact: Thomas Ala, MD         
United States, Indiana
IU Health Partners, Adult Neurology Clinic /ID# 151861 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Clinical and Translational Science Unit /ID# 151554 Recruiting
Fairway, Kansas, United States, 66205
United States, Kentucky
Univerisity of Kentucky /ID# 152753 Recruiting
Lexington, Kentucky, United States, 40504
United States, Maryland
Johns Hopkins Bayview Medical Center /ID# 151893 Recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Brighan and Women's Physicians Org Inc /ID# 151882 Recruiting
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital /ID# 151770 Recruiting
Charlestown, Massachusetts, United States, 02129
United States, New Jersey
Global Medical Institutes, LLC /ID# 152934 Recruiting
Princeton, New Jersey, United States, 08540
United States, New York
Scott Research Inc. /ID# 151880 Recruiting
Laurelton, New York, United States, 11413
The Feinstein Institute for Medical Research /ID# 151632 Recruiting
Manhasset, New York, United States, 11030
NYU Langone Medical Center /ID# 151862 Not yet recruiting
New York, New York, United States, 10016
United States, North Carolina
Duke Neurological Disorder Clinic /ID# 147828 Recruiting
Durham, North Carolina, United States, 27705
Contact: Jim Burke, MD         
United States, Oregon
Oregon Health & Science University (OHSU) /ID# 151690 Recruiting
Portland, Oregon, United States, 97239
United States, Rhode Island
Rhode Island Hospital /ID# 151538 Recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University Medical Center /ID# 154547 Recruiting
Nashville, Tennessee, United States, 37212
Contact: Lealani Acosta, MD         
United States, Texas
Presbyterian Hospital of Dallas /ID# 147815 Recruiting
Dallas, Texas, United States, 75231
Contact: Diana Kerwin, MD         
Nantz National Alzheimer Center /ID# 154810 Recruiting
Houston, Texas, United States, 77030
United States, Utah
University of Utah /ID# 151858 Recruiting
Salt Lake City, Utah, United States, 84108
United States, Virginia
Integrated Neurology Services /ID# 154863 Recruiting
Falls Church, Virginia, United States, 22043
Australia
St Vincent´s Hospital /ID# 152632 Recruiting
Darlinghurst, Australia, 2010
Griffith University /ID# 152635 Recruiting
Eastwood, Australia, 4222
Australian Alzheimer's Research Foundation /ID# 152634 Recruiting
Nedlands, Australia, 6009
Neurodegenerative Disorders Research Pty Ltd /ID# 152826 Recruiting
West Perth, Australia, 6005
Belgium
Universitair Ziekenhuis Leuven /ID# 152642 Not yet recruiting
Leuven, Belgium, 3000
Canada
Parkwood Institute /ID# 164204 Not yet recruiting
London, Canada, N6C0A7
Toronto Memory Program /ID# 147863 Recruiting
Toronto, Canada, M3B 2S7
Denmark
Hukommelsesklinikken /ID# 153192 Not yet recruiting
Kobenhavn, Denmark, 2100
Finland
Ita-Suomen Yliopisto /ID# 152959 Recruiting
Kuopio, Finland, 70210
Clinical Research Services Turku - CRST Oy /ID# 152845 Recruiting
Turku, Finland, 20520
Italy
AUSL Modena /ID# 152394 Not yet recruiting
Baggiovara (MO), Italy, 41126
IRCCS - San Giovanni di Dio - Fatebenefratelli /ID# 152395 Recruiting
Brescia, Italy, 25125
IRCCS Ca Granda Ospedale Policlinico Maggiore /ID# 152401 Not yet recruiting
Milano, Italy, 20122
ASST Grande Ospedale Metropolitano Niguarda /ID# 152391 Not yet recruiting
Milano, Italy, 20162
Universita degli Studi di Perugia /ID# 152397 Recruiting
Perugia, Italy, 06132
La Fondazione Policlinico Universitario Agostino Gemelli /ID# 152396 Recruiting
Rome, Italy, 00168
New Zealand
Princess Margaret Hospital /ID# 152827 Recruiting
Christchurch, New Zealand, 8022
Spain
Fundacio ACE /ID# 152643 Recruiting
Barcelona, Spain, 08028
Hospital Clinic de Barcelona /ID# 152646 Recruiting
Barcelona, Spain, 08036
Hospital Universitario Clinico San Carlos /ID# 153703 Recruiting
Madrid, Spain, 28040
Hospital Universitario Doce de Octubre /ID# 152647 Recruiting
Madrid, Spain, 28041
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Hana Florian, MD AbbVie
More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02880956     History of Changes
Other Study ID Numbers: M15-566
2016-001634-10 ( EudraCT Number )
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by AbbVie:
Tau
Nervous system diseases
Memory loss
Mild Alzheimer's Disease (AD)
Early Alzheimer's Disease
Early dementia
Mild Cognitive Impairment (MCI)
AD
Tauopathies
Neurodegenerative diseases

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders