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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 belowSelect...
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:Select...
My dementia is not caused by Alzheimer's but another condition like FTD or Parkinson's.
Select...
I do not have uncontrolled high blood pressure, diabetes, thyroid, heart, liver, or kidney disease.
Select...
I do not have any significant brain diseases other than Alzheimer's.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 48 through 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 48 through 96 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Evaluation of safety and tolerability of AL002: Incidence of adverse events
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
2021
Completed Phase 2
~450
Find a Location
Who is running the clinical trial?
Alector Inc.Lead Sponsor
10 Previous Clinical Trials
935 Total Patients Enrolled
AbbVieIndustry Sponsor
1,035 Previous Clinical Trials
522,663 Total Patients Enrolled
TBD TBDPrincipal Investigator
6 Previous Clinical Trials
1,274 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any significant brain diseases other than Alzheimer's.I am not pregnant, breastfeeding, nor planning to conceive during the study.My previous cancer has not fully resolved.You have a good memory and cognitive abilities, with a score of 22 or more on a memory test and a CDR Global Score between 0.5 and 1.0. Additionally, you scored 85 or lower on a specific cognitive test.I have early Alzheimer's with confirmed amyloid buildup in my brain.I do not have uncontrolled high blood pressure, diabetes, thyroid, heart, liver, or kidney disease.I have not received any experimental vaccines or gene therapy.I live in a long-term care facility or need constant nursing care.My dementia is not caused by Alzheimer's but another condition like FTD or Parkinson's.I am currently taking blood thinner medications.
Research Study Groups:
This trial has the following groups:- Group 1: AL002 Dose 1
- Group 2: Placebo
- Group 3: AL002 Dose 2
- Group 4: AL002 Dose 3
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04592874 — Phase 2