Clinical trial NCT03712787: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
Official title: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 364
Sex: ALL
Minimum age (years): 57
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs
timeFrame: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
measure: Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values
timeFrame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
measure: Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
timeFrame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period
timeFrame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
measure: Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
timeFrame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University of Arizona Medical Center Phoenix /ID# 203959
state: Arizona
city: Irvine
country: United States
facility: Irvine Clinical Research /ID# 204000
state: California
city: La Jolla
country: United States
facility: Ucsd /Id# 204001
state: California
city: San Francisco
country: United States
facility: University of California, San /ID# 204011
state: California
city: Delray Beach
country: United States
facility: Brain Matters Research /ID# 203957
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest Florida /ID# 203956
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 203995
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc. /ID# 203992
state: Florida
city: Tampa
country: United States
facility: University of South Florida /ID# 204009
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc /ID# 204010
state: Florida
city: Atlanta
country: United States
facility: Emory University / Emory Brain Health Center /ID# 203999
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net, LLC /ID# 204004
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital /ID# 203993
state: Illinois
city: Springfield
country: United States
facility: Southern IL Univ School of Med /ID# 203952
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University /ID# 203989
state: Indiana
city: Fairway
country: United States
facility: University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 203996
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 203954
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Physicians /ID# 204003
state: Massachusetts
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic /ID# 213435
state: Mississippi
city: Princeton
country: United States
facility: Princeton Medical Institute /ID# 203953
state: New Jersey
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 203994
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr /ID# 203958
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University /ID# 203997
state: Oregon
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies LLC /ID# 213183
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital /ID# 204005
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center /ID# 203951
state: Tennessee
city: Dallas
country: United States
facility: Kerwin Research Center /ID# 203998
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital /ID# 204002
state: Texas
city: Houston
country: United States
facility: McGovern Medical School /ID# 213312
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 203991
state: Utah
city: Alexandria
country: United States
facility: Integrated Neurology Services /ID# 203990
state: Virginia
city: Darlinghurst
country: Australia
facility: St Vincent's Centre for Applied Medical Research /ID# 204903
state: New South Wales
city: Southport
country: Australia
facility: Griffith University /ID# 204905
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Health /ID# 204906
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Res Fou /ID# 204904
state: Western Australia
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 204963
state: Bruxelles-Capitale
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 204965
state: Vlaams-Brabant
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 204964
city: London
country: Canada
facility: Parkwood Institute /ID# 204121
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program /ID# 204120
state: Ontario
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet /ID# 204591
state: Hovedstaden
city: Turku
country: Finland
facility: Clinical Research Services Turku /ID# 205924
state: Varsinais-Suomi
city: Kuopio
country: Finland
facility: Ita-Suomen Yliopisto /ID# 204538
city: Modena
country: Italy
facility: AOU di Modena /ID# 203904
state: Emilia-Romagna
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 203906
state: Lazio
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia /ID# 203905
state: Umbria
city: Brescia
country: Italy
facility: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
city: Burwood
country: New Zealand
facility: CGM Research Trust /ID# 204907
city: Donostia
country: Spain
facility: Fundacion CITA Alzheimer Fundazioa /ID# 204521
state: Pais Vasco
city: Barcelona
country: Spain
facility: Fundacio ACE /ID# 204520
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 204519
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 204518
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge /ID# 203900
state: Stockholms Lan
city: Molndal
country: Sweden
facility: Sahlgrenska University Hospital Molndal /ID# 203899
state: Vastra Gotalands Lan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: