A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

• Status: Recruiting
• Trial end date: 2023-08-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alector Inc.
• Collaborator: AbbVie

Criteria

Inclusion Criteria:

• Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET

• MMSE score ≥ 22 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤85.

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

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

Exclusion Criteria:

• 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.

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

• Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.

• History or evidence of clinically significant brain disease other than AD.

• Females who are pregnant or breastfeeding, or planning to conceive within the study period.

• Any experimental vaccine or gene therapy.

• History of unresolved cancer.

• Current use of anticoagulant medications.

• Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.