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Long-Term Follow-up of Gene Therapy for APOE4 Homozygote Alzheimer's Disease

Study acronym: LEADLTFU
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Trial status: Enrolling by Invitation to Active, Not Recruitingv11
  2. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Enrollment target: 9 to 10
    v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v9
  4. Enrollment target: 15 to 9
    • Study description expanded, about 7 words
    • Site details revised at 2 of 2 sites
    v8
  5. Primary completion date: Dec 2027 to Nov 2028
    • Study completion date: Jun 2028 to Nov 2028
    v7
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  1. Study sites: 3 to 2v6
  2. Site contacts updated at 1 of 3 sitesv5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2022 to May 8, 2023
    • Study sites: 1 to 3
    • Study description expanded, about 7 words
    v4
  4. Start date: Sep 2022 to Nov 2022v3
  5. Start date: Jun 2022 to Sep 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Lexeo Therapeutics
7 trials monitored
See 1 trial at risk
Dementia
1,978 trials monitored
See 106 trials at risk
Alzheimer's Disease
1,253 trials monitored
See 71 trials at risk
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 Alzheimer's disease in Study LX100101. A secondary objective is to assess the biomarker as shown by the conversion of CSF APOE isoforms from APOE4 to APOE2-APOE4. Additional secondary outcomes include amyloid PET scan, CSF markers (including Aβ42, Aβ42/Aβ40 ratio T--tau, and P-tau), and quantitative MRI (and other biomarkers that may be informative for this therapeutic approach). Other secondary objectives include instruments to assess cognitive and clinical AD and to evaluate if treatment with AAVrh.10hAPOE2 improves brain tau pathology with tau PET scan (LX1001-01 Cohorts 3 and 4 only).
Trial Details
NCT Number NCT05400330
Lead Sponsor Lexeo Therapeutics
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov