1. To assess the long-term safety and tolerability of ABBV-8E12 in subjects with early Alzheimer's disease (AD).2. To assess the pharmacokinetics (PK) of ABBV-8E12 in subjects with early AD.The exploratory objectives of this study are:• To…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurologisch
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events, vital signs, physical examination, neurologic examination,
electrocardiogram (ECG), laboratory tests, Columbian Suicide Severity Rating
Scale (C-SSRS), MRI, and immunogenicity assessments.
Timepoint of evaluation: Week 280
Secondary outcome
Pharmacokinetics (Clearance and Volume of Distribution)
Timepoint of evaluation: Week 280
Background summary
Alzheimer's disease (AD) is the most prevalent neurodegenerative disease among
the elderly population and the most common cause of dementia. At present,
approved pharmacological therapy for AD consists of symptomatic treatment.
Thus, there is a medical need for treatment modifying the course of the disease
on a biological level.
ABBV-8E12 is a humanized antibody being studied to target the tau protein,
which is thought to stabilize intracellular structures required for maintenance
and transport in neurons. Abnormal accumulation of altered tau protein is a
hallmark in a variety of neurodegenerative conditions, where the development of
tau pathology strongly correlates with clinical disease progression.
Study objective
1. To assess the long-term safety and tolerability of ABBV-8E12 in subjects
with early Alzheimer's disease (AD).
2. To assess the pharmacokinetics (PK) of ABBV-8E12 in subjects with early AD.
The exploratory objectives of this study are:
• To assess the long-term efficacy of ABBV-8E12 in slowing disease progression
in subjects with early AD. • To assess the long-term effect of ABBV-8E12 on a
range of disease-related and drug-related biomarkers in subjects with early AD.
Study design
A Phase 2 extension of Study M15-566 evaluating the long-term safety and
tolerability of ABBV-8E12 in subjects with early Alzheimer's disease.
The study will consist of a 5-year treatment period and a follow-up period of
approximately 20 weeks following the last study drug administration.
Intervention
Eligible subjects will receive ABBV-8E12 via intravenous (IV) infusion on Day 1
of Study M15-570 as follows:
• Subjects who received placebo in Study M15-566 will receive 2000 mg ABBV-8E12
in Study M15-570;
• Subjects who received 300 mg ABBV-8E12 in Study M15-566 will receive 1000 mg
ABBV-8E12 in Study M15-570; and
• Subjects who received 1000 mg or 2000 mg ABBV-8E12 in Study M15-566 will
continue on the same dose in Study M15-570.
Note: if any changes are made to alter Study M15-566 with regards to the
treatment arms due to safety, efficacy, or other reasons, a corresponding
change will be implemented in Study M15-570. This change may include, but is
not limited to, adding or dropping treatment arm(s).
Study burden and risks
Subjects participating in this trial will experience a higher burden compared
to standard of care. The subject will visit the hospital more frequent and
spend more time during visits. Subject will receive IV infusion of ABBV-8E12
and undergo various procedures; these include blood sampling and questionnaires.
So far, no notable safety findings were discovered. The benefit risk profile
will be further defined in this trial.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
- Subject has voluntarily provided written informed consent
- Subject completed the 96-week treatment period of Study M15-566.
- 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.
- The study partner has provided written informed consent.
- If female, subject must be postmenopausal or permanently surgically sterile
(bilateral oophorectomy, bilateral salpingectomy or
hysterectomy).
- If the male subject is sexually active with female partner(s) of childbearing
potential, he must agree, from Study Day 1 through 20 weeks after the last dose
of study drug to practice the protocol specified contraception and must refrain
from sperm donation.
Exclusion criteria
- Subject has any significant change in his/her medical condition since
participation in Study M15-566 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. This would include any
clinically significant neurological, hematological, autoimmune, endocrine,
cardiovascular, neoplastic, renal, hepatic, metabolic, psychiatric, pulmonary,
gastrointestinal, or other major disorder or contraindication to or inability
to tolerate brain MRI or PET scans.
- More than 8 weeks have elapsed since the subject received his/her last dose
of study drug in Study M15-566.
- Subject is concurrently enrolled in another interventional clinical study
(with the exception of Study M15-566) involving a therapeutic agent.
- Subject is considered by the investigator to be an unsuitable candidate to
receive ABBV-8E12 or the subject is considered by the investigator to be unable
or unlikely to comply with the dosing schedule or study evaluations.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-000268-26-NL |
| ClinicalTrials.gov | NCT03712787 |
| CCMO | NL70032.028.20 |