A Phase 1 interventional study of AL001 and Placebo in Healthy and Frontotemporal Dementia, sponsored by Alector Inc.. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by Alector Inc. · Phase 1, Interventional, and Treatment
A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics
This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK and PD of intravenously administered AL001 in Healthy Volunteers and FTD-GRN mutation carriers.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 64 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Alector Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Up to six single ascending doses of AL001
Biological: AL001
Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects
Other: Placebo
Active dose of AL001
Saline solution administered as a single infusion as palcebo.
Evaluation of safety and tolerability of AL001 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
Time frame: 85 days
Pharmacokinetics (PK) of AL001
Serum and cerebrospinal fluid (CSF) concentration of AL001 at specified time points
Time frame: 85 days
Maximum plasma concentration (Cmax) for AL001
Evaluate Cmax for serum and CSF concentration of AL001 at specified time points
Time frame: 85 days
Area under the curve concentration (AUC) for AL001
Evaluate AUC for serum and CSF concentration of AL001 at specified time points
Time frame: 85 days
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Alector Inc.