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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
Must not have
Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 48 through 96 weeks

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.
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).
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My dementia is not caused by Alzheimer's but another condition like FTD or Parkinson's.
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I do not have uncontrolled high blood pressure, diabetes, thyroid, heart, liver, or kidney disease.
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I do not have any significant brain diseases other than Alzheimer's.
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I am not pregnant, breastfeeding, nor planning to conceive during the study.
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I have not received any experimental vaccines or gene therapy.
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My previous cancer has not fully resolved.
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I am currently taking blood thinner medications.
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I live in a long-term care facility or need constant nursing care.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease progression as measured by the CDR-SB
Secondary study objectives
Change in ADAS-Cog13 score
Change in ADCOMS score
Change in ADCS-ADL-MCI score
+3 more
Other study objectives
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

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
935 Total Patients Enrolled
AbbVieIndustry Sponsor
1,020 Previous Clinical Trials
519,800 Total Patients Enrolled
TBD TBDPrincipal Investigator
6 Previous Clinical Trials
1,274 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
~69 spots leftby Nov 2025
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