Alzheimer's Disease, Healthy Volunteer
Conditions
Brief summary
The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.
Interventions
DRUGBIIB076
Administered as single intravenous (IV) infusion
DRUGPlacebo
Administered as single IV infusion
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria - Healthy Participants * Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Key Inclusion Criteria - Participants with Alzheimer's Disease (AD) * Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD according to the National Institutes of Aging-Alzheimer's Association \[McKhann 2011\], and in addition must have the following: * Clinical Dementia Rating (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD. * CDR Memory Box Score of ≥0.5. * Mini-Mental State Examination score between 18 and 30 (inclusive) at Screening. * Must have amyloid beta positivity confirmed at Screening Key
Exclusion criteria
- Healthy Participants * Brain MRI findings that might pose a risk to the participant, or might prevent a satisfactory MRI assessment for safety monitoring. * History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator. * Current enrollment in any other drug, biologic, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days (6 months for biologics) or 5 half-lives, whichever is longer, prior to Day-1. * Contraindications to having a brain MRI (e.g., pacemaker; MRI-incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed). * Contraindications to having an Lumbar Puncture (LP). Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 20 | Safety surveillance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| PK parameter of BIIB076: Maximum observed concentration (Cmax) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| BIIB076 serum pharmacokinetics (PK) concentration levels | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| PK parameter of BIIB076: Clearance (CL) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| PK parameter of BIIB076: Volume of distribution (Vd) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
| Number of participants with positive serum BIIB076 antibodies | Up to Week 20 | Serological assessment (of anti-BIIB076 antibodies in blood) |
| PK parameter of BIIB076: Terminal elimination half-life (t1/2) | Up to Week 20 | Assessment of BIIB076 pharmacokinetics in blood |
Countries
United States
Outcome results
None listed