AL002 for Alzheimer's Disease

No longer recruiting at 60 trial locations

Overseen By James Okoronkwo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Alector Inc.

Disqualifiers: Inability to consent, Safety discontinuation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: Long-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety, tolerability, and effectiveness of a treatment called AL002 for individuals with early Alzheimer's disease. Administered every four weeks, the study will explore different doses to determine the most effective one. As a long-term study, it will examine results over an extended period. Individuals who completed a previous related study and have a caregiver spending at least 10 hours a week with them might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the AL002 trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial team for guidance.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that AL002 has been tested for safety in people with early Alzheimer's Disease. In one study, participants tolerated a single dose of AL002 well, experiencing no serious health issues from the treatment.

These results come from studies where participants received several doses of AL002 every four weeks. The goal of these studies is to ensure the treatment's safety for long-term use. Since AL002 is in a phase that evaluates both safety and effectiveness, there is already some confidence in its safety for people. However, it's important to remember that all medications can have side effects, and individual experiences may differ. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Most treatments for Alzheimer's disease, like donepezil or memantine, work by addressing symptoms or slowing progression. AL002 is unique because it targets a specific immune pathway in the brain, potentially altering the disease's progression at a more fundamental level. This approach might help reduce the build-up of harmful proteins in the brain, offering a new way to tackle Alzheimer's beyond symptom management. Researchers are excited because this could lead to more effective interventions that not only manage symptoms but also modify the disease's course.

What evidence suggests that this trial's treatments could be effective for Alzheimer's Disease?

Research shows that AL002 has been tested for its potential to treat early Alzheimer's disease. Previous studies found that although AL002 is generally safe and can reach the brain, it did not significantly slow the disease compared to those who didn't take it. Patients on AL002 showed little improvement in slowing the disease's progress. However, the treatment was safe, with no serious side effects linked to the drug. More research is needed to determine if AL002 might work better in other ways or under different conditions. ^{1 3 4 6 7}

Who Is on the Research Team?

TBD TBD

Principal Investigator

Are You a Good Fit for This Trial?

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.

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 who were prematurely and permanently discontinued from treatment in the parent study for safety reasons

Participation deemed inappropriate per Investigator discretion

I am considered unable to give consent for medical procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AL002 every 4 weeks

Long-term

Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AL002

Trial Overview 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.

How Is the Trial Designed?

Group I: AL002 Dose 3 Experimental Treatment 1 Intervention

AL002 every 4 weeks

Group II: AL002 Dose 2 Experimental Treatment 1 Intervention

AL002 every 4 weeks

Group III: AL002 Dose 1 Experimental Treatment 1 Intervention

AL002 every 4 weeks

Who Is Running the Clinical Trial?

Alector Inc.

Lead Sponsor

Trials

11

Recruited

1,300+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. investors.alector.com investors.alector.com/news-releases/news-release-details/alector-announces-results-al002-invoke-2-phase-2-trial

Alector Announces Results from AL002 INVOKE-2 Phase 2 ... However, AL002 failed to meet the primary endpoint of slowing of Alzheimer's clinical progression as measured by the Clinical Dementia Rating ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04592874

A Phase 2 Study to Evaluate Efficacy and Safety of AL002 ... A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

3. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-024-01599-1

Preclinical and first-in-human evaluation of AL002, a novel ... Single-dose AL002 showed central nervous system penetrance and was well tolerated, with no treatment-related serious adverse events over 12 ...

4. neurologylive.com neurologylive.com/view/al002-falls-short-phase-2-invoke-2-trial-early-alzheimer-disease

AL002 Falls Short in Phase 2 INVOKE-2 Trial of Early ... AL002 did not meet the primary endpoint of slowing Alzheimer's clinical progression, as measured by the Clinical Dementia Rating Sum of Boxes.

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.095594

Baseline characteristics for INVOKE‐2: a phase 2 randomized ... The clinical diagnosis at enrollment was mild cognitive impairment due to AD for 67% of participants and mild dementia due to AD for 33% of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39444037/

Preclinical and first-in-human evaluation of AL002, a novel ... Single-dose AL002 showed central nervous system penetrance and was well tolerated, with no treatment-related serious adverse events over 12 ...

7. alector.gcs-web.com alector.gcs-web.com/news-releases/news-release-details/alector-presents-baseline-characteristics-invoke-2-phase-2

Alector Presents Baseline Characteristics for INVOKE-2 Phase ... INVOKE-2 is the first global Phase 2 trial evaluating the safety and efficacy of a TREM2 agonist, AL002, in slowing disease progression in individuals with ...