Wellington, Florida 33449

  • Alzheimer Disease

Purpose:

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


Study summary:

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


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.


NCT ID:

NCT04592874


Primary Contact:

Principal Investigator
TBD TBD

Study Lead
Phone: 650-826-2454
Email: clinicaltrials@alector.com


Backup Contact:

N/A


Location Contact:

Wellington, Florida 33449
United States

Study Coordinator

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2021

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