1. To assess the efficacy of ABBV-8E12 in slowing disease progression (cognitive and functional impairment) in subjects with Early Alzheimer's Disease (AD) as measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB).2. To assess the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Neurologisch
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: CDR-SB at week 96.
Secondary outcome
Secondary endpoints are determined by various assessments: PK, MMSE,
ADAS-Cog-14, RBANS, ADCS-MCI-ADL-24, FAQ, UPSA-B, ADCS-CGIC-MCI. This will be
determined at 96 weeks.
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 efficacy of ABBV-8E12 in slowing disease progression
(cognitive and functional impairment) in subjects with Early Alzheimer's
Disease (AD) as measured by the Clinical Dementia Rating - Sum of Boxes
(CDR-SB).
2. To assess the long term safety of ABBV-8E12 for up to 96 weeks in subjects
with Early AD.
Study design
A phase-2, multiple dose, multicenter, multinational, randomized, double-blind,
placebo-controlled study designed to evaluate the efficacy and safety of
ABBV-8E12 in subjects with Early Alzheimer's disease. The study will consist of
a screening period, a 96-week double-blind treatment period and a follow-up
period of approximately 20 weeks following the last study drug administration.
Intervention
Subjects will be randomized to one of the 3 dose arms or placebo in a 1:1:1:1
ratio.
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 or
placebo 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.
Wegalaan 9
Hoofddorp 2132 JD
NL
Wegalaan 9
Hoofddorp 2132 JD
NL
Listed location countries
Age
Inclusion criteria
* Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:
- Clinical Dementia Rating (CDR)-Global Score of 0.5
- Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
- Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
* Subject has a positive amyloid Positron Emission Tomography (PET) scan.
* Subject has a Modified Hachinski Ischemic Scale (MHIS) score of 4.
* The subject has an identified, reliable, study partner (e.g., family member).
* If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.
Exclusion criteria
* Subject has any contraindications or inability to tolerate to brain magnetic resonance imaging (MRI), PET scans or lumbar puncture (optional).
* Subject has evidence of any other clinically significant neurological disorder other than Early AD.
* In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
* Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of screening Visit 1.
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 |
|---|---|
| Other | 02880956 |
| EudraCT | EUCTR2016-001634-10-NL |
| CCMO | NL62386.056.17 |