Status:
ACTIVE_NOT_RECRUITING
Long-Term Follow-up of Gene Therapy for APOE4 Homozygote Alzheimer's Disease
Lead Sponsor:
Lexeo Therapeutics
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The primary purpose of this long-term follow-up study is to assess the long-term safety profile of APOE4 homozygote participants who were administered gene therapy (LX1001) for the treatment of Alzhei...
Detailed Description
This is a long-term follow-up study to evaluate the safety following LX1001, a gene therapy, for participants who are APOE4 homozygotes with clinical diagnoses varying from MCI or dementia due to AD w...
Eligibility Criteria
Inclusion
- Participants who received LX1001 in study LX1001-01
Exclusion
- Participants with any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to participant safety
- Participants who agree not to post their personal medical data in relation to this study or any study information online, including social media sites, until all participants have completed all LX1001 clinical studies, including long-term follow-up.
Key Trial Info
Start Date :
May 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05400330
Start Date
May 8 2023
End Date
November 1 2028
Last Update
July 1 2025
Active Locations (2)
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1
PPD- Orlando Research Unit
Orlando, Florida, United States, 32806
2
Duke University
Durham, North Carolina, United States, 27708