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

Korábbi kezelés

• Any experimental vaccine or gene therapy.
• Current use of anticoagulant medications.

Más betegség

• 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.
• History of unresolved cancer.

Egyéb

• Females who are pregnant or breastfeeding, or planning to conceive within the study period.
• Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
• Participant is positive for presence of APOE e4/e4 genotype.

• Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
• MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
• 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).