Alzheimer Disease, Healthy
Conditions
Brief summary
The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy participants and participants with Alzheimer's disease.
Detailed description
The study will be divided into three parts: Part A, Part B and Part C. Part A consists of up to 6 sequential cohorts (Cohorts A1 to A6): -Cohorts A1 to A6: 8 healthy participants per cohort (aiming for an equal number of men and women): 6 randomized to Lu AF87908 and 2 randomized to placebo. Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3): -Cohorts B1 to B3: 4 Japanese and 4 Chinese healthy participants per cohort: 6 participants randomized to Lu AF87908 and 2 participants randomized to placebo. Part C consists of 2 sequential cohorts (Cohorts C1 and C4): -Cohort C1 will consist of 6 participants with Alzheimer's disease with 3:1 randomization scheme for active: placebo. Cohort C4 will consist of up to 8 participants. Cohort C4 participants will be randomized based on the randomization scheme from Cohort C1.
Interventions
DRUGPlacebo
Concentrate for solution for IV infusion
DRUGLu AF87908
Lu AF87908 concentrate for solution for intravenous (IV) infusion
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participants: -Men and women ≥18 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kilograms (kg)/square meter (m\^2) and a minimum weight of 50 kg. Participants with Alzheimer's disease: * Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA guidelines. * Mini-Mental State Examination (MMSE) of 15-30. * Clinical Dementia Scale (CDR) global score up to and including 2.0. * Confirmed or determined (via amyloid positron emission tomography \[PET\] scan) to be amyloid positive. * If on FDA approved Alzheimer's disease medication, the treatment has been stable for 4 months prior to Day 1. -≥50 years of age. * BMI ≥18 and ≤40 kg/m\^2 and a minimum weight of 50 kg.
Exclusion criteria
* Clinically relevant structural brain abnormality as assessed using magnetic resonance imaging (MRI). * Any past or current treatment with an anti-Abeta or anti-tau active vaccine. * Any past or current treatment with a monoclonal anti-tau antibody or a tau anti-sense oligomer within the last 6 months. * Treatment with covid-19, influenza or pneumonia vaccine within the last 30 days prior to dosing of investigational medicinal product (IMP). Other eligibility criteria may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events | From Day 0 to Day 84 | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination) |
| AUC(0-t) of Lu AF87908 | From Day 0 to Day 84 | Area under the plasma concentration curve for Lu AF87908 |
| Cmax of Lu AF87908 | From Day 0 to Day 84 | Maximum observed plasma concentration for Lu AF87908 |
| Tmax Lu AF87908 | From Day 0 to Day 84 | Nominal time of occurrence of Cmax of Lu AF97908 in plasma |
Countries
United States
Outcome results
None listed