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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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

Key facts

Study ID

NCT04592874

Run by

Alector Inc.

People needed

356

Starts

2021-01-22

Expected to finish

2024-09-12

Last updated by the study team

2025-10-29

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.
• Participant is positive for presence of APOE e4/e4 genotype.

Where it is running

• Woodlands Research Network, LLC - ERG — Rogers, Arkansas, United States
• ATP Clinical Research — Costa Mesa, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• South Florida Neurology Associates — Boca Raton, Florida, United States
• Brain Matters Research - ERG — Delray Beach, Florida, United States
• Charter Research — Lady Lake, Florida, United States
• ClinCloud, LLC — Maitland, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• K2 Winter Garden Ocoee — Ocoee, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Axiom Clinical Research FL — Tampa, Florida, United States
• K2 The Villages — The Villages, Florida, United States
• Alzheimers Research and Treatment Center — Wellington, Florida, United States
• Conquest Clinical Research (Winter Park) — Winter Park, Florida, United States
• Emory University — Atlanta, Georgia, United States
• AMITA Health Clinical Research Institute — Elk Grove Village, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• Boston Center for Memory — Newton, Massachusetts, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Advanced Clinical Institute — Neptune City, New Jersey, United States
• Feinstein Institute For MR — Manhasset, New York, United States
• Columbia University College of Physicians and Surgeons — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• SUNY Upstate Medical Center — Syracuse, New York, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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