safety of AL002 in participants with Early Alzheimer’s Disease.
– 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).
– 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
– 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
– 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.
- ATP Clinical Research, Costa Mesa, California, United States, 92626