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# Lexeo Fast Track for Alzheimer’s Therapy
- URL: https://www.fdaweb.com/lexeo-fast-track-for-alzheimers-therapy/
- Published: 2021-04-22T12:00:00.000Z
- Updated: 2026-09-14T16:55:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149173

FDA has granted Lexeo Therapeutics a fast track designation for LX1001, an adeno-associated virus (AAV) mediated gene therapy for treating apolipoprotein E4- (APOE4) associated Alzheimer’s disease. The central nervous system-administered therapy is being evaluated in an ongoing Phase 1 clinical trial.

*“*APOE is the major transporter of cholesterol in the brain with prevailing evidence suggesting that it is a major genetic risk factor in the pathogenesis of the disease,” the company says. “Inheritance risk for APOE4 results in more frequent and earlier age of onset for developing Alzheimer’s disease while inheritance of APOE2, a protective APOE gene variant, has the reverse effect. LX1001 is an AAV mediated gene therapy being developed to deliver the protective APOE2 gene to the central nervous system.”

Lexeo says an ongoing open label, dose-ranging Phase 1 clinical trial ([NCT0363400](https://www.globenewswire.com/Tracker?data=QWUiAaZVEjvFwQC9r6G35a2Mlbj1zAFVSOATqujpUZDv14KR7irm1NovtZCSX9eXiSJvg-9Y18zCfjXpAg8RSAm9NoLxNqZAmXbnUEFFu0S3xRiK4NyPjIElQiL8A-6OzlIqv0cmxlWIjGEp%5F4W5Rg==&ref=fdaweb.com)) is evaluating LX1001 as a potential one-time treatment for early-stage Alzheimer's disease patients with mild cognitive impairment who are APOE4 homozygous. The study is on schedule to complete dosing of 15 patients by the end of the year, and initial clinical data are expected in the second half of 2021, it says.