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This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL003.
The study will be conducted in 2 phases:
In the single ascending dose (SAD) phase, up to approximately 42 healthy adult participants will be sequentially enrolled into up to approximately 7 cohorts. In the multiple-dose (MD) phase, approximately 12 patients with mild to moderate Alzheimer's disease will be enrolled in one cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL003 by intravenous (IV) infusion | Active Comparator | Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in single cohort |
|
| Placebo by intravenous (IV) infusion | Placebo Comparator | Matching saline solution will be administered for placebo subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL003 | Biological | Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE) | Incidence of adverse events during the treatment and follow up periods through out the study. | 141 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of AL003 | Serum and CSF concentration of AL003 at specific time points | 85 days |
| Maximum concentration (Cmax) for AL003 | Evaluate Cmax for serum and CSF concentration of AL003 at specified time points |
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Inclusion Criteria:
For MD cohort
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Paul, MD | Alector Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Matters Research | Delray Beach | Florida | 33445 | United States | ||
| Charter Research |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Saline Solution | Other | Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo |
|
| 85 days |
| Area under the curve concentration (AUC) for AL003 | Evaluate AUC for serum and CSF concentration of AL003 at specified time points | 85 days |
| Lady Lake |
| Florida |
| 32159 |
| United States |
| PPD Clinical Research Unit | Orlando | Florida | 32806 | United States |
| Synexus AES | The Villages | Florida | 32162 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Nucleus Network | Melbourne | Australia |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |