Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL002 · 2 trials · 2 indications
Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
| Arm | Type | Description |
|---|---|---|
| AL002 Dose 1 | EXPERIMENTAL | AL002 every 4 weeks |
| AL002 Dose 2 | EXPERIMENTAL | AL002 every 4 weeks |
| AL002 Dose 3 | EXPERIMENTAL | AL002 every 4 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo every 4 weeks |
| AL002 | ACTIVE_COMPARATOR | AL002 by intravenous (IV) infusion |
| Saline Solution | PLACEBO_COMPARATOR | placebo by intravenous (IV) infusion |
| Name | Type | Description |
|---|---|---|
| AL002 | DRUG | Administered via intravenous (IV) infusion |
| Placebo | DRUG | Administered via intravenous (IV) infusion |
| Saline Solution | OTHER | Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients |
Inclusion Criteria: * Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET * MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95. * Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a...
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AL002 is an investigational monoclonal antibody being developed by Alector, Inc. for Alzheimer disease. It is designed as a disease-modifying therapy for early Alzheimer disease and has been studied in two completed clinical trials, a Phase 1 study in healthy volunteers and patients and a Phase 2 study in early Alzheimer disease.
AL002 is being developed for the treatment of early Alzheimer disease. It is not an approved therapy. Its Phase 2 study enrolled 356 participants with early Alzheimer disease across the United States, Argentina, Australia, Canada, France, Germany, Italy, the Netherlands, New Zealand, Poland, Spain, and the United Kingdom.
AL002 is developed by Alector, Inc., a biotechnology company whose common stock trades under the ticker symbol ALEC. Alector is the sponsor of the clinical program evaluating AL002 in Alzheimer disease.
AL002 is in Phase 2 development. Both of its clinical trials are completed: a Phase 1 safety and tolerability study and a Phase 2 efficacy and safety study in participants with early Alzheimer disease. AL002 is investigational and has not been approved by the FDA.
AL002 has been evaluated in two completed trials. NCT04592874 was a Phase 2 study of AL002 in participants with early Alzheimer disease that enrolled 356 people. NCT03635047 was a Phase 1 study of AL002 for safety and tolerability that enrolled 69 participants, including healthy volunteers.
The Phase 2 trial of AL002, NCT04592874, was a randomized, double-blind, placebo-controlled study in participants with early Alzheimer disease. It enrolled 356 participants aged 50 years and older of any sex and was conducted across sites in the United States, Europe, Canada, Australia, and New Zealand.