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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02880956
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : December 20, 2018
Information provided by (Responsible Party):

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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
Actual Study Start Date : October 17, 2016
Estimated Primary Completion Date : December 16, 2020
Estimated Study Completion Date : September 23, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 2
Dose 2 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion

Experimental: Group 3
Dose 3 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion

Experimental: Group 1
Dose 1 ABBV-8E12
Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion

Placebo Comparator: Group 4
Placebo for ABBV-8E12
Drug: placebo for ABBV-8E12
placebo solution for IV infusion

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 112 weeks ]
  2. Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Week 96 ]
    A scale used to quantify the severity of symptoms of dementia.

Secondary Outcome Measures :
  1. 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).

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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Neuropsychiatry Inventory (NPI) [ Time Frame: 96 weeks ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.

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 identifier (NCT number): NCT02880956

Contact: ABBVIE CALL CENTER 847.283.8955

  Hide Study Locations
United States, Arizona
Banner University MC Phoenix /ID# 151536 Recruiting
Phoenix, Arizona, United States, 85006
Banner Sun Health Res Inst /ID# 151895 Recruiting
Sun City, Arizona, United States, 85351
United States, California
Irvine Clinical Research /ID# 162331 Recruiting
Irvine, California, United States, 92614
Ctipm @ Actri /Id# 152467 Not yet recruiting
La Jolla, California, United States, 92037
Ray Dolby Brain Health Center /ID# 154965 Recruiting
San Francisco, California, United States, 94113
Univ California, San Francisco /ID# 152053 Recruiting
San Francisco, California, United States, 94143-2204
United States, Florida
Brain Matters Research /ID# 147796 Recruiting
Delray Beach, Florida, United States, 33445
Southwest Florida Neuropsych /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, 33612
Compass Research, LLC /ID# 151633 Recruiting
The Villages, Florida, United States, 32162
United States, Georgia
Emory University Hospital /ID# 151492 Recruiting
Atlanta, Georgia, United States, 30322
Atlanta Center for Medical Res /ID# 151550 Recruiting
Atlanta, Georgia, United States, 30331, LLC /ID# 152746 Recruiting
Decatur, Georgia, United States, 30033
United States, Illinois
Great Lakes Clinical Trials /ID# 152754 Recruiting
Chicago, Illinois, United States, 60640
Advocate Lutheran General Hosp /ID# 152052 Recruiting
Park Ridge, Illinois, United States, 60068
Southern IL Univ School of Med /ID# 151769 Recruiting
Springfield, Illinois, United States, 62702
United States, Indiana
Indiana University /ID# 151861 Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 151554 Recruiting
Fairway, Kansas, United States, 66205
United States, Kentucky
University of Kentucky Chandler Medical Center /ID# 152753 Recruiting
Lexington, Kentucky, United States, 40536
United States, Maryland
Johns Hopkins Bayview Med Cnt /ID# 151893 Not yet recruiting
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital /ID# 151770 Recruiting
Boston, Massachusetts, United States, 02114
Brigham and Women's Physicians /ID# 151882 Recruiting
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Med Ctr /ID# 202913 Not yet recruiting
Boston, Massachusetts, United States, 02215-5400
United States, Mississippi
Hattiesburg Clinic /ID# 202388 Not yet recruiting
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Princeton Medical Institute /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
North Shore University Hospital /ID# 151632 Recruiting
New Hyde Park, New York, United States, 11040
United States, North Carolina
Duke Univ Med Ctr /ID# 147828 Recruiting
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health and Science University /ID# 151690 Recruiting
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Keystone Clinical Studies LLC /ID# 202305 Not yet recruiting
Norristown, Pennsylvania, United States, 19403-5239
United States, Rhode Island
Rhode Island Hospital /ID# 151538 Recruiting
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 154547 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Kerwin Research Center /ID# 147815 Recruiting
Dallas, Texas, United States, 75231-4316
Houston Methodist Hospital /ID# 154810 Recruiting
Houston, Texas, United States, 77030
McGovern Medical School /ID# 204860 Not yet recruiting
Houston, Texas, United States, 77054
United States, Utah
University of Utah /ID# 151858 Recruiting
Salt Lake City, Utah, United States, 84112-5500
United States, Virginia
Integrated Neurology Services /ID# 154863 Recruiting
Alexandria, Virginia, United States, 22310
Australia, New South Wales
St. Vincent's Hospital, Darlinghurst /ID# 152632 Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Griffith University /ID# 152635 Recruiting
Southport, Queensland, Australia, 4222
Australia, Victoria
Austin Hospital /ID# 152637 Recruiting
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital /ID# 202633 Not yet recruiting
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Australian Alzheimer's Res Fou /ID# 152634 Recruiting
Nedlands, Western Australia, Australia, 6009
Neurodegenerative Disorders Re /ID# 152826 Not yet recruiting
West Perth, Western Australia, Australia, 6005
Cliniques Universitaires Saint Luc /ID# 152847 Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Leuven /ID# 152642 Recruiting
Leuven, Belgium, 3000
CHC Liege /ID# 152846 Recruiting
Liege, Belgium, 4000
Canada, British Columbia
University of British Columbia /ID# 169377 Not yet recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Canada, Ontario
Parkwood Institute /ID# 164204 Recruiting
London, Ontario, Canada, N6C 5J1
Toronto Memory Program /ID# 147863 Recruiting
Toronto, Ontario, Canada, M3B 2S7
Rigshospitalet, Memory Clinic /ID# 153192 Recruiting
Copenhagen Ø, Hovedstaden, Denmark, 2100
Clinical Research Services Turku /ID# 152845 Recruiting
Turku, Varsinais-Suomi, Finland, 20520
Ita-Suomen Yliopisto /ID# 152959 Recruiting
Kuopio, Finland, 70210
AOU di Modena /ID# 152394 Recruiting
Modena, Emilia-Romagna, Italy, 41126
AO Univ Policlinico Agostino G /ID# 152396 Recruiting
Rome, Lazio, Italy, 00168
AOU Policlinico Umberto I /ID# 163144 Not yet recruiting
Rome, Lazio, Italy, 00185
ASST Grande Ospedale Metropolitano Niguarda /ID# 152391 Recruiting
Milano, Lombardia, Italy, 20162
IRCCS - San Giovanni di /ID# 152395 Recruiting
Brescia, Italy, 25125
Fondazione IRCCS Cà Granda Osp /ID# 152401 Recruiting
Milan, Italy, 20122
Azienda Ospedaliera di Perugia /ID# 152397 Recruiting
Perugia, Italy, 06126
Hyogo Brain and Heart Center /ID# 209526 Not yet recruiting
Himeji-shi, Hyogo, Japan, 670-0981
Rakuwakai Otowarehabilitation Hospital /ID# 209330 Not yet recruiting
Kyoto-shi, Kyoto, Japan, 607-8113
National Hospital Organization Matsumoto Medical Center /ID# 209289 Not yet recruiting
Matsumoto-shi, Nagano, Japan, 3998701
Shizuoka Institute of Epilepsy and Neurological Disorders /ID# 209208 Not yet recruiting
Shizuoka-shi, Shizuoka, Japan, 420-8688
Universitair Medisch Centrum Utrecht /ID# 163576 Recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
CGM Research Trust /ID# 152827 Recruiting
Burwood Christchurch, New Zealand, 8083
Fundacion CITA Alzheimer /ID# 152645 Recruiting
Donostia, Pais Vasco, Spain, 20009
Hospital Clinic de Barcelona /ID# 152646 Recruiting
Barcelona, Spain, 08036
Fundacio ACE /ID# 152643 Recruiting
Barcelona, Spain, 8028
Hospital Clin Univ San Carlos /ID# 153703 Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario Doce de /ID# 152647 Recruiting
Madrid, Spain, 28041
Sahlgrenska US Mölndal /ID# 154465 Recruiting
Mölndal, Vastra Gotalands Lan, Sweden, 431 80
Karolinska University Hospital /ID# 156705 Recruiting
Huddinge, Sweden, 141 86
Sponsors and Collaborators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie 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: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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