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Monoclonal Antibodies

AL002 for Early Alzheimer's Disease (INVOKE-2 Trial)

Phase 2
Waitlist Available
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
Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 48 through 96 weeks
Awards & highlights

INVOKE-2 Trial Summary

This trial is testing whether a new drug, AL002, is effective and safe in people with early Alzheimer's disease.

Who is the study for?
This trial is for people with early Alzheimer's Disease who score at least 22 on the MMSE, have a CDR Global Score of 0.5 - 1.0, and an RBANS DMI score ≤85. They must have evidence of brain amyloidosis and a study partner available for support. Excluded are those with severe allergies to certain proteins, uncontrolled health conditions like hypertension or diabetes, significant non-AD brain diseases, pregnant or breastfeeding women, and users of anticoagulants.Check my eligibility
What is being tested?
The trial tests AL002 against a placebo in participants with early Alzheimer's Disease to see if it's effective and safe. Participants will be randomly assigned to either receive AL002 or a placebo without knowing which one they're getting (double-blind).See study design
What are the potential side effects?
While specific side effects for AL002 aren't listed here, common risks may include allergic reactions due to its antibody nature; potential side effects often seen in similar treatments could range from mild injection site reactions to more serious immune-related responses.

INVOKE-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have early Alzheimer's with confirmed amyloid buildup in my brain.

INVOKE-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 48 through 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 48 through 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease progression as measured by the CDR-SB
Secondary outcome measures
Change in ADAS-Cog13 score
Change in ADCOMS score
Change in ADCS-ADL-MCI score
+3 more
Other outcome measures
Change in CSF biomarkers (optional)
Change in Winterlight Language Speech Assessment score (optional)
Change in amyloid burden as assessed by positron emission tomography imaging (optional)
+3 more

INVOKE-2 Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
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
Group IV: PlaceboPlacebo Group1 Intervention
Placebo every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AL002
2018
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Alector Inc.Lead Sponsor
10 Previous Clinical Trials
957 Total Patients Enrolled
AbbVieIndustry Sponsor
954 Previous Clinical Trials
500,716 Total Patients Enrolled
TBD TBDPrincipal Investigator
6 Previous Clinical Trials
1,296 Total Patients Enrolled

Media Library

AL002 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04592874 — Phase 2
Alzheimer's Disease Research Study Groups: AL002 Dose 1, Placebo, AL002 Dose 2, AL002 Dose 3
Alzheimer's Disease Clinical Trial 2023: AL002 Highlights & Side Effects. Trial Name: NCT04592874 — Phase 2
AL002 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592874 — Phase 2
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04592874 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to individuals of advanced age?

"As specified in the inclusion criteria of this research, participants must be between 50 to 85 years old."

Answered by AI

What safety protocols are in place to ensure the efficacy of AL002 for human use?

"The safety profile of AL002 received a rating of 2 since this is a Phase 2 trial, implying that while there are data backing its security, no evidence has been found to support the drug's efficacy."

Answered by AI

How many participants have been recruited to partake in this clinical experiment?

"AbbVie, the sponsor of this medical trial, requires 265 participants that meet their eligibility criteria to conduct the study. It will be launched at ATP Clinical Research in Costa Mesa and Parkwood Institute in London."

Answered by AI

Do I meet the requirements to partake in this investigation?

"This medical trial has a set of criteria which potential participants must meet, including being aged between 50 and 85 with alzheimer's disease. The current aim is to enrol 265 subjects in total."

Answered by AI

Are there still vacancies available for participation in this experiment?

"Per records on clinicaltrials.gov, this trial is open to new participants. The study was first unveiled January 22nd 2021 and has been modified as recently as July 21st 2022."

Answered by AI

How many healthcare centers are offering participation in this clinical research?

"This medical experiment is being conducted in 31 distinct locations, including ATP Clinical Research (Costa Mesa, California), Parkwood Institute (London, Ontario) and the University of Rochester Medical Center (Rochester, New york)."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
1
What site did they apply to?
University of Texas - San Antonio
Georgetown University Medical Center
Clinical Trial Network

Why did patients apply to this trial?

Desperate to find some help. I see a neuro doc as i have mild cognitive issues. She has me taking donepezil.
PatientReceived 2+ prior treatments
I feel I may be declining fast. I really need help and in the process contribute to finding help for victims of this. I understand it is so much better to catch the disease as soon as you can and that is why it is so important to me at this time.
PatientReceived 2+ prior treatments
I've was diagnosed two years ago with mild cognitive decline and now my neurologist says I am in the early stages of Alzheimer's Disease. I want to see if I can slow down the progression of this disease. Please note that my wife, Mary Kathleen Franklin, is my caregiver/study partner and she is submitting this to you from her email. Please call her if you have any questions. She has medical POA. Thank you.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the study slated to last? When will we find out about screening?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
2021. "A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04592874.
All > Alzheimer Disease > Alzheimers Disease
~37 spots leftby Oct 2024
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