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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03712787
• Other study ID #: M15-570
• Secondary ID: 2018-000268-26
• Status: Terminated
• Phase: Phase 2
• Start date: March 22, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 364
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 57 Years to 88 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Tilavonemab
solution for IV infusion

Locations

Country	Name	City	State
Australia	St Vincent's Centre for Applied Medical Research /ID# 204903	Darlinghurst	New South Wales
Australia	Austin Health /ID# 204906	Heidelberg	Victoria
Australia	Australian Alzheimer's Res Fou /ID# 204904	Nedlands	Western Australia
Australia	Griffith University /ID# 204905	Southport	Queensland
Belgium	Universitair Ziekenhuis Leuven /ID# 204965	Leuven	Vlaams-Brabant
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 204964	Liege
Belgium	UCL Saint-Luc /ID# 204963	Woluwe-Saint-Lambert	Bruxelles-Capitale
Canada	Parkwood Institute /ID# 204121	London	Ontario
Canada	Toronto Memory Program /ID# 204120	Toronto	Ontario
Denmark	Rigshospitalet /ID# 204591	Copenhagen Ø	Hovedstaden
Finland	Ita-Suomen Yliopisto /ID# 204538	Kuopio
Finland	Clinical Research Services Turku /ID# 205924	Turku	Varsinais-Suomi
Italy	IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903	Brescia
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902	Milan
Italy	ASST Grande Ospedale Metropolitano Niguarda /ID# 203901	Milano
Italy	AOU di Modena /ID# 203904	Modena	Emilia-Romagna
Italy	Azienda Ospedaliera di Perugia /ID# 203905	Perugia	Umbria
Italy	Policlinico Agostino Gemelli /ID# 203906	Rome	Lazio
New Zealand	CGM Research Trust /ID# 204907	Burwood
Spain	Fundacio ACE /ID# 204520	Barcelona
Spain	Hospital Clinic de Barcelona /ID# 204519	Barcelona
Spain	Fundacion CITA Alzheimer Fundazioa /ID# 204521	Donostia	Pais Vasco
Spain	Hospital Universitario 12 de Octubre /ID# 204518	Madrid
Sweden	Sahlgrenska University Hospital Molndal /ID# 203899	Molndal	Vastra Gotalands Lan
Sweden	Karolinska University Hospital Huddinge /ID# 203900	Stockholm	Stockholms Lan
United States	Integrated Neurology Services /ID# 203990	Alexandria	Virginia
United States	Emory University / Emory Brain Health Center /ID# 203999	Atlanta	Georgia
United States	Brigham and Women's Physicians /ID# 204003	Boston	Massachusetts
United States	Massachusetts General Hospital /ID# 203954	Boston	Massachusetts
United States	Kerwin Research Center /ID# 203998	Dallas	Texas
United States	NeuroStudies.net, LLC /ID# 204004	Decatur	Georgia
United States	Brain Matters Research /ID# 203957	Delray Beach	Florida
United States	Duke Univ Med Ctr /ID# 203958	Durham	North Carolina
United States	University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960	Fairway	Kansas
United States	Neuropsychiatric Research Center of Southwest Florida /ID# 203956	Fort Myers	Florida
United States	Hattiesburg Clinic /ID# 213435	Hattiesburg	Mississippi
United States	Houston Methodist Hospital /ID# 204002	Houston	Texas
United States	McGovern Medical School /ID# 213312	Houston	Texas
United States	Indiana University /ID# 203989	Indianapolis	Indiana
United States	Irvine Clinical Research /ID# 204000	Irvine	California
United States	Mayo Clinic /ID# 203995	Jacksonville	Florida
United States	Ucsd /Id# 204001	La Jolla	California
United States	University of Kentucky Chandler Medical Center /ID# 203996	Lexington	Kentucky
United States	Vanderbilt Ingram Cancer Center /ID# 203951	Nashville	Tennessee
United States	North Shore University Hospital /ID# 203994	New Hyde Park	New York
United States	Synexus Clinical Research US, Inc. /ID# 203992	Orlando	Florida
United States	Advocate Lutheran General Hospital /ID# 203993	Park Ridge	Illinois
United States	Banner University of Arizona Medical Center Phoenix /ID# 203959	Phoenix	Arizona
United States	Keystone Clinical Studies LLC /ID# 213183	Plymouth Meeting	Pennsylvania
United States	Oregon Health and Science University /ID# 203997	Portland	Oregon
United States	Princeton Medical Institute /ID# 203953	Princeton	New Jersey
United States	Rhode Island Hospital /ID# 204005	Providence	Rhode Island
United States	University of Utah /ID# 203991	Salt Lake City	Utah
United States	University of California, San /ID# 204011	San Francisco	California
United States	Southern IL Univ School of Med /ID# 203952	Springfield	Illinois
United States	University of South Florida /ID# 204009	Tampa	Florida
United States	Synexus Clinical Research US, Inc /ID# 204010	The Villages	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Finland,  Italy,  New Zealand,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs	Treatment emergent adverse events (TEAEs) are defined as any adverse event (AE) from the time of study drug administration until 20 weeks after discontinuation of study drug. An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any event that: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome. Severity of AEs was categorized as mild, moderate, or severe. Relationship of the AE to the study treatment was categorized as having a reasonable possibility or no reasonable possibility.	From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary	Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values	Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary	Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values	Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period	The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.	Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Primary	Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease		Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.