NCT05744401Phase 2Terminated

A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

Study sponsor: Alector Inc. · ALEC

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2025-01-31Actual
Enrollment · participants197Actual
Source updated2026-02-25Last update listed in the registry record
Version history

Changes to this trial

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· 1 field changed

Primary outcomes · main study measures

Text 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

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· 1 field changed

Primary outcomes · main study measures

Text 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

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· 2 fields changed

Primary outcomes · main study measures

Text 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

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

Enrollment · participant count

Recorded edit
− Previous value

count: 198; type: ACTUAL

+ Updated value

count: 197; type: ACTUAL

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