198 Participants Needed

AL002 for Alzheimer's Disease

Recruiting at 53 trial locations
DN
JC
DC
SM
JM
AS
FM
JO
Overseen ByJames Okoronkwo
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Alector Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

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.

How does the drug AL002 differ from other Alzheimer's treatments?

AL002 is unique because it targets a specific sequence (31-35) in the amyloid beta protein, which is believed to be a key area responsible for the neurotoxicity seen in Alzheimer's disease. This approach may offer a novel way to protect neurons and improve memory and learning by preventing damage caused by amyloid beta.12345

Research Team

TT

TBD TBD

Principal Investigator

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
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

Find a Clinic Near You

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

References

The pathomimetic oAβ25-35 model of Alzheimer's disease: Potential for screening of new therapeutic agents. [2023]
The associations of APP, PSEN1, and PSEN2 genes with Alzheimer's disease: A large case-control study in Chinese population. [2023]
Neurodegeneration, synaptic dysfunction, and gliosis are phenotypic of Alzheimer dementia. [2019]
A novel antibody targeting sequence 31-35 in amyloid β protein attenuates Alzheimer's disease-related neuronal damage. [2018]
Association study between Alzheimer's disease and restriction fragment length polymorphisms at the human amyloid beta protein gene locus. [2010]
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