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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer’s Disease


Brief Summary:

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


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

– 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
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