Sponsors / ALEC
ALEC

Alector Inc.

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6Trials in this database
16Recorded changes · last 12 months
Partial coverageOnly the trials and history collected so far

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

Completion dates · Pro

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Included trials

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TrialSponsorPhaseStatusPrimary completion
A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)NCT03987295ALECPhase 2Completed2024-06-05Actual
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)NCT04374136ALECPhase 3Terminated2025-09-01Actual
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's DiseaseNCT04592874ALECPhase 2Completed2024-08-19Actual
A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALSNCT05053035ALECPhase 2Terminated2022-10-28Actual
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's DiseaseNCT05744401ALECPhase 2Terminated2025-01-31Actual
Continuation Study for LatozinemabNCT06111014ALECPhase 3Terminated2025-09-01Actual

Latest recorded trial changes

A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)

NCT04374136 · Alector Inc.

Primary outcomes · main study measuresText edit · unverified significance
− Previous value

measure: Evaluation of efficacy of AL001 as measured by the CDR® plus NACC FTLD-SB

+ Updated value

measure: Part 1 Double Blind - Evaluation of Efficacy of AL001 Compared With Placebo as Measured by the CDR® Plus NACC FTLD-SB in Symptomatic Patients; measure: Part 1 Double Blind (Co-Primary US Endpoint) - Evaluation of the Treatment Effect of AL001 Compared With Placebo as Measured by Pharmacodynamic and Disease Pathology Biomarkers in Symptomatic Patients; measure: Part 2 OLE - To Assess the Long-term Safety and Tolerability of AL001 in Participants Who Have Completed Part 1 of the Study

Check registry source · The saved outcome text may be shortened. Check the source for full wording.
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

NCT05744401 · Alector Inc.

Primary outcomes · main study measuresText edit · unverified significance
− Previous value

measure: Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).; measure: Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events; measure: Safety and Tolerability as Measured by the Number of Cases of Abnormal Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.; measure: To Evaluate the Long-term Safety and Tolerability of AL002 by Assessing Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS); measure: To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E; measure: To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H

+ Updated value

measure: Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).; measure: Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events; measure: Safety and Tolerability as Measured by the Number of Cases of Abnormal Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.; measure: To Evaluate the Long-term Safety and Tolerability of AL002, by Assessing the Number of Suicidal Risk Events Using the Columbia-Suicide Severity Rating Scale (C-SSRS); measure: To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events; measure: To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events

Check registry source · The saved outcome text may be shortened. Check the source for full wording.
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

NCT05744401 · Alector Inc.

Primary outcomes · main study measuresText edit · unverified significance
− Previous value

measure: Safety and Tolerability as Measured by Number of/Incidence of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).; measure: Safety and Tolerability as Measured by Number of/Incidence of Adverse Events of Special Interest and Serious Adverse Events; measure: Safety and Tolerability as Measured in Evaluation of Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.; measure: To Evaluate the Long-term Safety and Tolerability of AL002 Utilizing the Columbia-Suicide Severity Rating Scale (C-SSRS); measure: To Evaluate the Effect of Dose Titration on ARIA-E; measure: To Evaluate the Effect of Dose Titration on ARIA-H

+ Updated value

measure: Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).; measure: Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events; measure: Safety and Tolerability as Measured by the Number of Cases of Abnormal Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.; measure: To Evaluate the Long-term Safety and Tolerability of AL002 by Assessing Suicidality Using the Columbia-Suicide Severity Rating Scale (C-SSRS); measure: To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E; measure: To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H

Check registry source · The saved outcome text may be shortened. Check the source for full wording.
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

NCT05744401 · Alector Inc.

Primary outcomes · main study measuresText edit · unverified significance
− Previous value

measure: Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs.; measure: Safety and tolerability as measured by the number of incidence/MRI abnormalities.

+ Updated value

measure: Safety and Tolerability as Measured by Number of/Incidence of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).; measure: Safety and Tolerability as Measured by Number of/Incidence of Adverse Events of Special Interest and Serious Adverse Events; measure: Safety and Tolerability as Measured in Evaluation of Vital Signs, Clinical Laboratory Results and Findings From Physical, Neurological, Ophthalmological Examinations and Electrocardiograms.; measure: To Evaluate the Long-term Safety and Tolerability of AL002 Utilizing the Columbia-Suicide Severity Rating Scale (C-SSRS); measure: To Evaluate the Effect of Dose Titration on ARIA-E; measure: To Evaluate the Effect of Dose Titration on ARIA-H

Check registry source · The saved outcome text may be shortened. Check the source for full wording.
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

NCT04592874 · Alector Inc.

Primary outcomes · main study measuresText edit · unverified significance
− Previous value

measure: Disease Progression as Measured by the CDR-SB

+ Updated value

measure: Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Check registry source · The saved outcome text may be shortened. Check the source for full wording.