Trial · NCT05744401
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease
NCT05744401, Phase 2, Terminated, Alector Inc.; results first posted 2026-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease. Trials, record NCT05744401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05744401
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease
- NCT number
- NCT05744401
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Alector Inc.
- Conditions
- Alzheimer's Disease
- Interventions
- AL002
- First posted
- 2023-02-27
- Last updated
- 2026-02-25
- Results first posted
- 2026-02-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. | Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug. |
| Primary | Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. | Adverse Events are any untoward medical occurrence in a participant enrolled in this study, including side effects, injury, toxicity, sensitivity reaction, intercurrent illnesses, clinically significant physical exam signs, or sudden death, whether or not it is considered related to the study drug. |
| Primary | 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. | From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks | Evaluation of vital signs (blood pressure, pulse, temperature), clinical laboratory results (hematology, biochemistry, urinalysis), and findings from physical, neurological, ophthalmological examinations, and electrocardiograms. |
| Primary | 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) | From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks. | Two versions of the C-SSRS were used in the parent study: a Screening/Baseline version and a Since Last Visit version. The Screening/Baseline version of the C-SSRS assesses the lifetime suicidal ideation and behavior and non-suicidal self-injurious behavior, the suicidal ideation in the past 6 months, and suicidal behavior and non-suicidal self-injurious behavior in the past two years. The C-SSRS uses a point scale where a higher score indicates a greater risk of suicidality. |
| Primary | To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events | Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks | Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products in the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-E refers to MRI findings of vasogenic edema and leptomeningeal/sulcal effusion. |
| Primary | To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events | Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks | Among the brain abnormalities detected on MRI are ARIA, which are believed to reflect leakage of proteinaceous fluid or other blood products int the leptomeninges or brain parenchyma. The term ARIA was originally coined to describe specific brain abnormalities seen on MRI in anti-amyloid clinical trials. Specifically, according to the convention developed to describe ARIA occurring in clinical trials of anti-amyloid immunotherapies, ARIA-H refers to MRI findings of cerebral microhemorrhages, leptomeningeal hemosiderosis, and cerebral macrohemorrhages. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. | Occurrence of Adverse Event | NUMBER | |
| PRIMARY | Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events | From the Screening period and throughout the treatment period until the end of study participation, up to 49 weeks. | Occurrence of Adverse Event | NUMBER | |
| PRIMARY | 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. | From the Screening period and throughout the treatment period until the end of study completion, up to 49 weeks | Occurrence of Abnormal Findings | NUMBER | |
| PRIMARY | 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) | From the Screening period and throughout the treatment period until the end of the study participation up to 49 weeks. | Number of Participants | NUMBER | |
| PRIMARY | To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events | Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks | The analysis population for this outcome includes the parent study and the long term extension. | Number of Participants | NUMBER |
| PRIMARY | To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events | Screening, Week 9, Week 17, Week 25, Week 33, Week 41, End of Study visit, and Early Termination visit, if applicable up to 49 weeks | The analysis population for this outcome includes the parent study and the long term extension. | Number of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 15 mg/kg | TEAE: Death | 0 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 40 mg/kg | TEAE: Death | 0 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 60 mg/kg | TEAE: Death | 1 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | Titration Cohort | TEAE: Death | 0 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 15 mg/kg | TEAE: Severe | 1 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 40 mg/kg | TEAE: Severe | 0 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 60 mg/kg | TEAE: Severe | 2 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | Titration Cohort | TEAE: Severe | 4 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 15 mg/kg | TEAE: Moderate | 5 | Occurrence of Adverse Event | |
| Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs). | AL002 40 mg/kg | TEAE: Moderate | 3 | Occurrence of Adverse Event |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AL002 15 mg/kg | 41 | |
| Overall Study | STARTED | AL002 40 mg/kg | 49 | |
| Overall Study | STARTED | AL002 60 mg/kg | 43 | |
| Overall Study | STARTED | Titration Cohort | 64 | |
| Overall Study | COMPLETED | AL002 15 mg/kg | 4 | |
| Overall Study | COMPLETED | AL002 40 mg/kg | 7 | |
| Overall Study | COMPLETED | AL002 60 mg/kg | 5 | |
| Overall Study | COMPLETED | Titration Cohort | 3 | |
| Overall Study | NOT COMPLETED | AL002 15 mg/kg | 37 | |
| Overall Study | NOT COMPLETED | AL002 40 mg/kg | 42 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events304
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | AL002 15 mg/kg | 1 | 41 | |
| other | Anemia | Blood and lymphatic system disorders | AL002 40 mg/kg | 0 | 49 | |
| other | Anemia | Blood and lymphatic system disorders | AL002 60 mg/kg | 0 | 43 | |
| other | Anemia | Blood and lymphatic system disorders | Titration Cohort | 1 | 64 | |
| other | Leukopenia | Blood and lymphatic system disorders | AL002 15 mg/kg | 0 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | AL002 40 mg/kg | 0 | 49 | |
| other | Leukopenia | Blood and lymphatic system disorders | AL002 60 mg/kg | 1 | 43 | |
| other | Leukopenia | Blood and lymphatic system disorders | Titration Cohort | 0 | 64 | |
| other | Hypoacusis | Ear and labyrinth disorders | AL002 15 mg/kg | 0 | 41 | |
| other | Hypoacusis | Ear and labyrinth disorders | AL002 40 mg/kg | 0 | 49 |
1 to 10 of 304Source ClinicalTrials.gov
See all 304 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AL002 15 mg/kg | 0 | 41 |
| Total, all-cause mortality | AL002 40 mg/kg | 0 | 49 |
| Total, all-cause mortality | AL002 60 mg/kg | 1 | 43 |
| Total, all-cause mortality | Titration Cohort | 0 | 64 |
| Total, other adverse events | AL002 15 mg/kg | 16 | 41 |
| Total, other adverse events | AL002 40 mg/kg | 12 | 49 |
| Total, other adverse events | AL002 60 mg/kg | 33 | 43 |
| Total, other adverse events | Titration Cohort | 30 | 64 |
| Total, serious adverse events | AL002 15 mg/kg | 0 | 41 |
| Total, serious adverse events | AL002 40 mg/kg | 0 | 49 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05744401
GET https://conductscience.org/api/trials/v1/NCT05744401/results?page=2