What side effects are associated with this type of intervention?

Monoclonal antibodies targeting amyloid plaques, such as aducanumab, have been associated with side effects including amyloid-related imaging abnormalities (ARIA), which can manifest as brain swelling or microhemorrhages. Other side effects reported include headache, falls, diarrhea, and confusion. Cholinesterase inhibitors, another common treatment, can cause gastrointestinal issues like nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine, used for moderate to severe Alzheimer's, may lead to dizziness, headache, confusion, and constipation. These side effects should be discussed with a healthcare provider to tailor the best treatment plan for the patient.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease that target amyloid plaques, similar to the investigational drug AL002. Notably, aducanumab (Aduhelm) is a monoclonal antibody that targets amyloid-beta plaques and was approved in 2021. Another monoclonal antibody, lecanemab (Leqembi), also targets amyloid-beta and received accelerated approval in 2023. These treatments aim to reduce amyloid plaque buildup in the brain, which is associated with the progression of Alzheimer's Disease.

What other types of research exist?

Promising alternatives to AL002 for Alzheimer's Disease patients include solanezumab, which targets soluble Aβ peptides. Other potential treatments to consider are monoclonal antibodies like aducanumab and lecanemab, which also target amyloid plaques and are in various stages of clinical trials or approval processes.

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Monoclonal Antibodies

AL002 for Alzheimer's Disease

Phase 2

Recruiting

Led By TBD TBD

Research Sponsored by Alector Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests AL002, a drug for early Alzheimer's disease, in people who were part of an earlier study. It aims to check if AL002 is safe and effective over time.

Who is the study for?

This trial is for individuals with Early Alzheimer's Disease who completed the AL002-2 study, can consent to participate, and have a caregiver involved at least 10 hours weekly. Those unable to consent or discontinued from the previous study due to safety cannot join.

What is being tested?

The trial is testing the long-term effects of a drug called AL002 on safety, tolerability, and effectiveness in treating Early Alzheimer's Disease. It extends prior research by continuing treatment with this drug.

What are the potential side effects?

Specific side effects are not listed here but generally include any adverse reactions observed during the ongoing treatment with AL002. These could range from mild symptoms to more serious health concerns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: AL002 Dose 3Experimental Treatment1 Intervention

AL002 every 4 weeks

Group II: AL002 Dose 2Experimental Treatment1 Intervention

AL002 every 4 weeks

Group III: AL002 Dose 1Experimental Treatment1 Intervention

AL002 every 4 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AL002

2018

Completed Phase 1

~70

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil, rivastigmine), which work by increasing levels of acetylcholine in the brain to help improve cognitive function, and NMDA receptor antagonists (e.g., memantine), which regulate glutamate activity to prevent excitotoxicity and neuronal damage. Monoclonal antibodies, such as those targeting amyloid plaques (e.g., aducanumab), aim to reduce amyloid-beta accumulation, potentially slowing disease progression. These treatments are crucial as they address different aspects of Alzheimer's pathology, offering symptomatic relief and potentially modifying disease progression, which is vital for improving the quality of life for patients.

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Who is running the clinical trial?

Alector Inc.Lead Sponsor

10 Previous Clinical Trials

1,075 Total Patients Enrolled

AbbVieIndustry Sponsor

1,004 Previous Clinical Trials

513,568 Total Patients Enrolled

TBD TBDPrincipal Investigator

6 Previous Clinical Trials

1,414 Total Patients Enrolled

Media Library

AL002 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05744401 — Phase 2

Alzheimer's Disease Research Study Groups: AL002 Dose 1, AL002 Dose 2, AL002 Dose 3

Alzheimer's Disease Clinical Trial 2023: AL002 Highlights & Side Effects. Trial Name: NCT05744401 — Phase 2

AL002 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05744401 — Phase 2

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