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An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03712787
Collaborator
(none)
364
Enrollment
57
Locations
2
Arms
30.3
Actual Duration (Months)
6.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with early AD.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
364 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
Actual Study Start Date :
Mar 22, 2019
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABBV-8E12 Dose 1

Participants will receive ABBV-8E12 Dose 1.

Drug: ABBV-8E12
ABBV-8E12 solution for IV infusion
Other Names:
  • Tilavonemab

    		•
    Experimental: ABBV-8E12 Dose 2

    Participants will receive ABBV-8E12 Dose 2.

    Drug: ABBV-8E12
    ABBV-8E12 solution for IV infusion
    Other Names:
  • Tilavonemab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events [From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years)]

      Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 20 weeks after discontinuation of study drug.

    Secondary Outcome Measures

    1. Clearance of ABBV-8E12 [From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years)]

      Clearance (CL) of ABBV-8E12.

    2. Volume of distribution (V) [From first dose of study drug to 20 weeks after last dose of study drug (up to approximately 5.5 years)]

      Volume of distribution.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    57 Years to 87 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All subjects with early AD who complete Study M15-566 (NCT02880956), meet all inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment

    • Subject was compliant during participation in Study M15-566 (NCT02880956)

    • Subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities

    Exclusion Criteria:

    • The subject has any significant change in his/her medical condition since participation in Study M15-566 (NCT02880956) that could interfere with the subject's participation in Study M15-570, could place the subject at increased risk, or could confound interpretation of study results

    • More than 8 weeks have elapsed since the subject received his/her last dose of study drug in Study M15-566 (NCT02880956)

    • The subject is concurrently enrolled in another interventional clinical study involving a therapeutic agent with the exception of Study M15-566 (NCT02880956)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner University of Arizona Medical Center Phoenix /ID# 203959 Phoenix Arizona United States 85006
    2 Irvine Clinical Research /ID# 204000 Irvine California United States 92614
    3 Ucsd /Id# 204001 La Jolla California United States 92037
    4 University of California, San /ID# 204011 San Francisco California United States 94143-0633
    5 Brain Matters Research /ID# 203957 Delray Beach Florida United States 33445
    6 Neuropsychiatric Research Center of Southwest Florida /ID# 203956 Fort Myers Florida United States 33912
    7 Mayo Clinic /ID# 203995 Jacksonville Florida United States 32224
    8 Synexus Clinical Research US, Inc. /ID# 203992 Orlando Florida United States 32806-1044
    9 University of South Florida /ID# 204009 Tampa Florida United States 33612
    10 Synexus Clinical Research US, Inc /ID# 204010 The Villages Florida United States 32162-7116
    11 Emory University /ID# 203999 Atlanta Georgia United States 30322-1013
    12 NeuroStudies.net, LLC /ID# 204004 Decatur Georgia United States 30030
    13 Advocate Lutheran General Hospital /ID# 203993 Park Ridge Illinois United States 60068
    14 Southern IL Univ School of Med /ID# 203952 Springfield Illinois United States 62702
    15 Indiana University /ID# 203989 Indianapolis Indiana United States 46202
    16 University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960 Fairway Kansas United States 66205
    17 University of Kentucky Chandler Medical Center /ID# 203996 Lexington Kentucky United States 40536
    18 Massachusetts General Hospital /ID# 203954 Boston Massachusetts United States 02114
    19 Brigham and Women's Physicians /ID# 204003 Boston Massachusetts United States 02115
    20 Hattiesburg Clinic /ID# 213435 Hattiesburg Mississippi United States 39401
    21 Princeton Medical Institute /ID# 203953 Princeton New Jersey United States 08540
    22 North Shore University Hospital /ID# 203994 New Hyde Park New York United States 11040
    23 Duke Univ Med Ctr /ID# 203958 Durham North Carolina United States 27710
    24 Oregon Health and Science University /ID# 203997 Portland Oregon United States 97239
    25 Keystone Clinical Studies LLC /ID# 213183 Plymouth Meeting Pennsylvania United States 19462
    26 Rhode Island Hospital /ID# 204005 Providence Rhode Island United States 02903
    27 Vanderbilt Ingram Cancer Center /ID# 203951 Nashville Tennessee United States 37232-0021
    28 Kerwin Research Center /ID# 203998 Dallas Texas United States 75231-4316
    29 Houston Methodist Hospital /ID# 204002 Houston Texas United States 77030
    30 McGovern Medical School /ID# 213312 Houston Texas United States 77054
    31 University of Utah /ID# 203991 Salt Lake City Utah United States 84112-5500
    32 Integrated Neurology Services /ID# 203990 Alexandria Virginia United States 22310
    33 St Vincent's Centre for Applied Medical Research /ID# 204903 Darlinghurst New South Wales Australia 2010
    34 Griffith University /ID# 204905 Southport Queensland Australia 4222
    35 Austin Health /ID# 204906 Heidelberg Victoria Australia 3084
    36 Australian Alzheimer's Res Fou /ID# 204904 Nedlands Western Australia Australia 6009
    37 UCL Saint-Luc /ID# 204963 Woluwe-Saint-Lambert Bruxelles-Capitale Belgium 1200
    38 Universitair Ziekenhuis Leuven /ID# 204965 Leuven Vlaams-Brabant Belgium 3000
    39 Groupe Sante CHC - Clinique du MontLegia /ID# 204964 Liege Belgium 4000
    40 Parkwood Institute /ID# 204121 London Ontario Canada N6C 0A7
    41 Toronto Memory Program /ID# 204120 Toronto Ontario Canada M3B 2S7
    42 Rigshospitalet /ID# 204591 Copenhagen Ø Hovedstaden Denmark 2100
    43 Clinical Research Services Turku /ID# 205924 Turku Varsinais-Suomi Finland 20520
    44 Ita-Suomen Yliopisto /ID# 204538 Kuopio Finland 70210
    45 AOU di Modena /ID# 203904 Modena Emilia-Romagna Italy 41126
    46 Policlinico Agostino Gemelli /ID# 203906 Rome Lazio Italy 00168
    47 Azienda Ospedaliera di Perugia /ID# 203905 Perugia Umbria Italy 06129
    48 IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903 Brescia Italy 25125
    49 ASST Grande Ospedale Metropolitano Niguarda /ID# 203901 Milano Italy 20162
    50 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902 Milan Italy 20122
    51 CGM Research Trust /ID# 204907 Burwood New Zealand 8083
    52 Fundacion CITA Alzheimer Fundazioa /ID# 204521 Donostia Pais Vasco Spain 20009
    53 Fundacio ACE /ID# 204520 Barcelona Spain 08028
    54 Hospital Clinic de Barcelona /ID# 204519 Barcelona Spain 08036
    55 Hospital Universitario 12 de Octubre /ID# 204518 Madrid Spain 28041
    56 Karolinska University Hospital Huddinge /ID# 203900 Stockholm Stockholms Lan Sweden 171 77
    57 Sahlgrenska University Hospital Molndal /ID# 203899 Molndal Vastra Gotalands Lan Sweden 431 80

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03712787
    Other Study ID Numbers:
    • M15-570
    • 2018-000268-26
    First Posted:
    Oct 19, 2018
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Alzheimer Disease
    Tilavonemab

    Study Results

    No Results Posted as of Nov 16, 2021