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

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT05744401

Acronym / sponsor ID

AL002-LTE

Conditions

Alzheimer's Disease

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: Parent study failed to meet the primary endpoint and there were no treatment effects that favored AL002 on secondary clinical and functional endpoints.

Enrolment

197 participants (actual)

Lead sponsor

Alector Inc.Industry (pharma, biotech, devices)

Collaborators

AbbVie

Study start

4 Jan 2023 (actual)

Primary completion

31 Jan 2025 (actual)

Study completion

5 Feb 2025 (actual)

First posted

27 Feb 2023 (actual)

Results

Posted 25 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

3

Who may qualify

Ages

50 to 85 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Safety and Tolerability as Measured by Number of Treatment-expected Adverse Events (TEAE) and Treatment-related Adverse Events (AEs).

   Time frame: 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.

2. Safety and Tolerability as Measured by Number of Adverse Events of Special Interest and Serious Adverse Events

   Time frame: 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.

3. 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.

   Time frame: 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.

4. 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)

   Time frame: 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.

5. To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-E by Assessing the Number of Participants With ARIA-E Events

   Time frame: 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.

6. To Evaluate the Effect of Dose Titration on the Occurrence of ARIA-H by Assessing the Number of Participants With ARIA-H Events

   Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

54 sites in 10 countries: see every site and its status.