Alzheimer's DiseasePhase 2NCT03712787
An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD)
A Phase 2 study testing Tilavonemab in people with Alzheimer's Disease, run by AbbVie at 57 sites in 10 countries.
Trial summary
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD. Read more about this study
- Who is it for?
- Ages 57 to 88 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Tilavonemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 57 sitesin 10 countries
- Study dates
- 22 Mar 2019to 30 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 57 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
57 sites in 10 countries.
57 sites in 10 countries
United States32 sites
Integrated Neurology Services /ID# 203990
Alexandria, Virginia, 22310
Emory University / Emory Brain Health Center /ID# 203999
Atlanta, Georgia, 30329-2206
Massachusetts General Hospital /ID# 203954
Boston, Massachusetts, 02114
Brigham and Women's Physicians /ID# 204003
Boston, Massachusetts, 02115
Kerwin Research Center /ID# 203998
Dallas, Texas, 75231-4316
NeuroStudies.net, LLC /ID# 204004
Decatur, Georgia, 30030
Brain Matters Research /ID# 203957
Delray Beach, Florida, 33445
Duke Univ Med Ctr /ID# 203958
Durham, North Carolina, 27710
University of Kansas Medical Center - Alzheimer's Disease Center /ID# 203960
Fairway, Kansas, 66205
Neuropsychiatric Research Center of Southwest Florida /ID# 203956
Fort Myers, Florida, 33912
Hattiesburg Clinic /ID# 213435
Hattiesburg, Mississippi, 39401
Houston Methodist Hospital /ID# 204002
Houston, Texas, 77030
McGovern Medical School /ID# 213312
Houston, Texas, 77054
Indiana University /ID# 203989
Indianapolis, Indiana, 46202
Irvine Clinical Research /ID# 204000
Irvine, California, 92614
Mayo Clinic /ID# 203995
Jacksonville, Florida, 32224
Ucsd /Id# 204001
La Jolla, California, 92037
University of Kentucky Chandler Medical Center /ID# 203996
Lexington, Kentucky, 40536
Vanderbilt Ingram Cancer Center /ID# 203951
Nashville, Tennessee, 37232-0021
North Shore University Hospital /ID# 203994
New Hyde Park, New York, 11040
Synexus Clinical Research US, Inc. /ID# 203992
Orlando, Florida, 32806-1044
Advocate Lutheran General Hospital /ID# 203993
Park Ridge, Illinois, 60068
Banner University of Arizona Medical Center Phoenix /ID# 203959
Phoenix, Arizona, 85006
Keystone Clinical Studies LLC /ID# 213183
Plymouth Meeting, Pennsylvania, 19462
Oregon Health and Science University /ID# 203997
Portland, Oregon, 97239
Princeton Medical Institute /ID# 203953
Princeton, New Jersey, 08540
Rhode Island Hospital /ID# 204005
Providence, Rhode Island, 02903
University of Utah /ID# 203991
Salt Lake City, Utah, 84112-5500
University of California, San /ID# 204011
San Francisco, California, 94143-0633
Southern IL Univ School of Med /ID# 203952
Springfield, Illinois, 62702
University of South Florida /ID# 204009
Tampa, Florida, 33612
Synexus Clinical Research US, Inc /ID# 204010
The Villages, Florida, 32162-7116
Italy6 sites
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli /ID# 203903
Brescia, 25125
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 203902
Milan, 20122
ASST Grande Ospedale Metropolitano Niguarda /ID# 203901
Milan, 20162
AOU di Modena /ID# 203904
Modena, Emilia-Romagna, 41126
Azienda Ospedaliera di Perugia /ID# 203905
Perugia, Umbria, 06129
Policlinico Agostino Gemelli /ID# 203906
Rome, Lazio, 00168
Australia4 sites
St Vincent's Centre for Applied Medical Research /ID# 204903
Darlinghurst, New South Wales, 2010
Austin Health /ID# 204906
Heidelberg, Victoria, 3084
Australian Alzheimer's Res Fou /ID# 204904
Nedlands, Western Australia, 6009
Griffith University /ID# 204905
Southport, Queensland, 4222
Spain4 sites
Fundacio ACE /ID# 204520
Barcelona, 08028
Hospital Clinic de Barcelona /ID# 204519
Barcelona, 08036
Fundacion CITA Alzheimer Fundazioa /ID# 204521
Donostia / San Sebastian, Basque Country, 20009
Hospital Universitario 12 de Octubre /ID# 204518
Madrid, 28041
Belgium3 sites
Universitair Ziekenhuis Leuven /ID# 204965
Leuven, Vlaams-Brabant, 3000
Groupe Sante CHC - Clinique du MontLegia /ID# 204964
Liège, 4000
UCL Saint-Luc /ID# 204963
Woluwe-Saint-Lambert, Brussels Capital, 1200
Canada2 sites
Parkwood Institute /ID# 204121
London, Ontario, N6C 0A7
Toronto Memory Program /ID# 204120
Toronto, Ontario, M3B 2S7
Finland2 sites
Ita-Suomen Yliopisto /ID# 204538
Kuopio, 70210
Clinical Research Services Turku /ID# 205924
Turku, Southwest Finland, 20520
Sweden2 sites
Sahlgrenska University Hospital Molndal /ID# 203899
Mölndal, Västra Götaland County, 431 80
Karolinska University Hospital Huddinge /ID# 203900
Stockholm, Stockholm County, 171 77
About this study
Official title: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.
- Conditions
- Alzheimer's Disease
- Being tested
- Tilavonemab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TilavonemabDrug
Also called ABBV-8E12
solution for IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 300 mg/1000 mg Tilavonemab | Experimental | Participants who received 300 mg tilavonemab in Study M15-566 receive 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks for up to 5.5 years. Receives: Drug: Tilavonemab |
| 1000 mg/1000 mg Tilavonemab | Experimental | Participants who received 1000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years. Receives: Drug: Tilavonemab |
| 2000 mg/2000 mg Tilavonemab | Experimental | Participants who received 2000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years. Receives: Drug: Tilavonemab |
| PBO/2000 mg Tilavonemab | Experimental | Participants who received placebo (PBO) in Study M15-566 receive 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years. Receives: Drug: Tilavonemab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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.
Measured: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
Measured: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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.
Measured: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
Measured: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start22 Mar 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712787
- Sponsor's protocol ID
- M15-570
- Other IDs
- 2018-000268-26, 2018
- Status last verified
- Aug 2022
- First submitted
- 18 Oct 2018
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of ABBV-8E12 in Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03712787
- Acronym / sponsor ID
- M15-570
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956).
- Enrolment
- 364 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in participants with early AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 300 mg/1000 mg Tilavonemab | Experimental | Drug: TilavonemabParticipants who received 300 mg tilavonemab in Study M15-566 receive 1000 mg tilavonemab in Study M15-570 via intravenous (IV) infusion every 4 weeks for up to 5.5 years. |
| 1000 mg/1000 mg Tilavonemab | Experimental | Drug: TilavonemabParticipants who received 1000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years. |
| 2000 mg/2000 mg Tilavonemab | Experimental | Drug: TilavonemabParticipants who received 2000 mg tilavonemab in Study M15-566 continue on the same dose in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years. |
| PBO/2000 mg Tilavonemab | Experimental | Drug: TilavonemabParticipants who received placebo (PBO) in Study M15-566 receive 2000 mg tilavonemab in Study M15-570 via IV infusion every 4 weeks for up to 5.5 years. |
Who may qualify
- Ages
- 57 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TilavonemabAlso: ABBV-8E12solution for IV infusion | Drug | 1000 mg/1000 mg Tilavonemab, 2000 mg/2000 mg Tilavonemab, 300 mg/1000 mg Tilavonemab, PBO/2000 mg Tilavonemab |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs
Time frame: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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.
Hematology: Number of Participants With Postbaseline Potentially Clinically Significant (PCS) Values
Time frame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Clinical laboratory PCS criteria were adapted from National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Clinical Chemistry: Percentage of Participants With Postbaseline PCS Values
Time frame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Clinical laboratory PCS criteria were adapted from NCI CTCAE version 4.03
Columbia-Suicide Severity Rating Scale (C-SSRS) During Double-Blind Treatment Period
Time frame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
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.
Brain Magnetic Resonance Imaging (MRI) Results: Number of Participants With Cerebral Edemas, New Microhemorrhage(s), and Severe White Matter Disease
Time frame: Baseline to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
57 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tilavonemab in people with Alzheimer's Disease, run by AbbVie at 57 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Italy, Australia, Spain, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Study Drug, and Fatal TEAEs (time frame: From first dose of study drug to 20 weeks after last dose of study drug; overall median time on treatment was 279 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.