Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lu AF87908 or Placebo | Experimental | Participants in Cohorts A1 to A6 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. |
|
| Part B: Lu AF87908 or Placebo | Experimental | Participants in Cohorts B1 to B3 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. |
|
| Part C: Lu AF87908 or Placebo | Experimental | Participants in Cohorts C1 and C4 will receive a single dose of either Lu AF87908 or matching placebo at specific dose levels on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF87908 | Drug | Lu AF87908 concentrate for solution for intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events | Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination) | From Day 0 to Day 84 |
| AUC(0-t) of Lu AF87908 | Area under the plasma concentration curve for Lu AF87908 | From Day 0 to Day 84 |
| Cmax of Lu AF87908 | Maximum observed plasma concentration for Lu AF87908 | From Day 0 to Day 84 |
| Tmax Lu AF87908 | Nominal time of occurrence of Cmax of Lu AF97908 in plasma | From Day 0 to Day 84 |
Not provided
Not provided
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:
Other eligibility criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International | Glendale | California | 91206 | United States | ||
| Research Center of America |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Concentrate for solution for IV infusion |
|
| Hollywood |
| Florida |
| 33024 |
| United States |
| Panax Clinical Research | Miami | Florida | 33014 | United States |
| iResearch Atlanta LLC | Decatur | Georgia | 30030 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Clinilabs, Inc. | New York | New York | 10019 | United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |