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

Recruiting in Palo Alto (17 mi)

+96 other locations

Overseen byTBD TBD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alector Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

TBD TBD

Principal Investigator

Eligibility Criteria

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.

Inclusion Criteria

Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week

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.

Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).

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Exclusion Criteria

Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.

I do not have any significant brain diseases other than Alzheimer's.

I am not pregnant, breastfeeding, nor planning to conceive during the study.

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Treatment Details

Interventions

AL002 (Monoclonal Antibodies)

Trial OverviewThe 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).

Participant Groups

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