AL001
Sponsors
Alector Inc., Alzamend Neuro, Inc.
Conditions
Alzheimer's DiseaseAmyotrophic Lateral SclerosisBipolar I DisorderFrontotemporal DementiaHealthyHealthy Non-elderly and Elderly AdultsNeurologyPharmacokinetics
Phase 1
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation
CompletedNCT03636204
Start: 2018-09-14End: 2019-12-31Updated: 2020-07-27
Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects
CompletedNCT05363293
Start: 2022-05-04End: 2023-05-15Updated: 2025-05-14
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
CompletedNCT06921590
Start: 2025-05-09End: 2025-12-15Updated: 2026-07-29
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
RecruitingNCT07540338
Start: 2026-05-11End: 2026-12-01Target: 20Updated: 2026-07-28
Phase 2
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)
CompletedNCT03987295
Start: 2019-09-27End: 2024-06-05Updated: 2025-12-05
A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS
TerminatedNCT05053035
Start: 2021-09-02End: 2022-10-28Updated: 2025-06-18