Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease

Launched by H. LUNDBECK A/S · Nov 1, 2019

Keywords

ClinConnect Summary

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 w...

Gender

ALL

Eligibility criteria

• • 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.