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

Long-term study of AL002 for Alzheimer's Disease (NCT05744401) - TERMINATED

NCT: NCT05744401 · Status: TERMINATED · Phase: Phase 2 · Sponsor: Alector Inc. · Started: 2023-01-04 · Est. Completion: 2025-02-05

Plain English Summary

A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease is a Phase 2 clinical trial sponsored by Alector Inc. studying Alzheimer's Disease. This study tested AL002, a drug given by IV infusion, in people with early Alzheimer's Disease. It was for individuals who had already completed the main treatment period of a previous study (AL002-2). Participation involved continuing to receive AL002 and regular safety monitoring. This was an extension study, meaning it followed participants from an earlier trial. The trial aims to enroll 197 participants.

Official Summary

A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.

Who Can Participate

Here is what you need to know about eligibility for this trial. People who finished the main treatment in the AL002-2 study. Individuals who can give informed consent and have a study partner who visits them at least 10 hours a week. People who were not previously removed from the AL002-2 study for safety reasons. Individuals who are not deemed unable to consent by the doctor or local rules. This trial is studying Alzheimer's Disease, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measured how safe and well-tolerated AL002 was by tracking side effects, serious adverse events, and changes in vital signs and lab results over time. The specific primary outcome measures are: 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.); 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.); 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); 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.); 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aimed to understand the long-term safety and effectiveness of AL002, a potential new treatment for early Alzheimer's disease, addressing a need for ongoing therapeutic options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Alzheimer's Disease, where improved treatment options are needed.

Investor Insight

This trial, sponsored by Alector Inc., was investigating a novel therapy for Alzheimer's Disease, a significant and growing market. The termination of this extension study may indicate challenges in d Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of continuing AL002 treatment. Understand what side effects might occur and how they will be monitored. Discuss the time commitment involved for regular visits and assessments. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Completion of the Planned Treatment Period in the AL002-2 study.
* The participant is willing and able to give informed consent.
* Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week

Exclusion Criteria:

* Participants deemed not able to provide consent or assent by the Investigator or by local regulations.
* Participants who were prematurely and permanently discontinued from treatment in the parent study for safety reasons.
* Participation deemed inappropriate per Investigator discretion.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05744401?

NCT05744401 is a Phase 2 INTERVENTIONAL study titled "A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease." It is currently terminated and is sponsored by Alector Inc.. The trial targets enrollment of 197 participants.

What conditions does NCT05744401 study?

This trial investigates treatments for Alzheimer's Disease. The primary condition under study is Alzheimer's Disease.

What treatments are being tested in NCT05744401?

The interventions being studied include: AL002 (DRUG). Administered via intravenous (IV) infusion

What does Phase 2 mean for NCT05744401?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT05744401?

This trial is currently "Terminated." It started on 2023-01-04. The estimated completion date is 2025-02-05.

Who is sponsoring NCT05744401?

NCT05744401 is sponsored by Alector Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05744401?

The trial aims to enroll 197 participants. The trial status is terminated.

How is NCT05744401 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT05744401?

The primary outcome measures are: 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.); 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.); 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); 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.); 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). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05744401 being conducted?

This trial is being conducted at 20 sites, including Phoenix, Arizona; Washington D.C., District of Columbia; Boca Raton, Florida; Lady Lake, Florida and 16 more sites (United States, Argentina, Australia).

Where can I find official information about NCT05744401?

The official record for NCT05744401 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05744401. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05744401 testing in simple terms?

This study tested AL002, a drug given by IV infusion, in people with early Alzheimer's Disease. It was for individuals who had already completed the main treatment period of a previous study (AL002-2).

Why is this trial significant?

This trial aimed to understand the long-term safety and effectiveness of AL002, a potential new treatment for early Alzheimer's disease, addressing a need for ongoing therapeutic options.

What are the potential risks of participating in NCT05744401?

The main risks involved monitoring for side effects, including any that are unexpected or serious. Specific attention was paid to suicidal thoughts or behaviors, and a condition called ARIA-E (swelling in the brain). Participants were monitored for abnormal vital signs, lab results, and findings from physical and eye exams. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05744401?

Ask your doctor about the specific risks and benefits of continuing AL002 treatment. Understand what side effects might occur and how they will be monitored. Discuss the time commitment involved for regular visits and assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05744401 signal from an investment perspective?

This trial, sponsored by Alector Inc., was investigating a novel therapy for Alzheimer's Disease, a significant and growing market. The termination of this extension study may indicate challenges in d This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participation involved continuing to receive AL002 and regular safety monitoring. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.