Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304883
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-03-05
Brief Title:
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE44 Early AD Subjects
Sponsor:
Alzheon Inc
Organization:
Alzheon Inc
Study Overview
Official Title:
Long-term Extension of a Phase 3 Multicenter Randomized Double-Blind Placebo- Controlled Study of the Efficacy Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimers Disease and APOE44 Genotype
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APOLLOE4-LTE
Brief Summary:
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimers disease AD subjects with the APOE44 genotype This is an open-label trial of treatment with ALZ-801
Detailed Description:
This is a long-term extension study of the Phase 3 multicenter randomized double-blind placebo-controlled study of the efficacy safety and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimers Disease and APOE44 genotype Subjects who at initial screening for the Phase 3 study were 50-80 years old had a clinical diagnosis of AD carried the APOE44 genotype and were at the early stage of disease Early AD who complete at least 78 weeks of the Phase 3 study while on study medication are eligible for enrollment Subjects will be treated for 52 weeks with ALZ-801 followed by a 4-week safety follow-up visit after the last dose of ALZ-801 Clinical trial sites subjects and their study partner will remain blinded to the treatment ALZ-801 or placebo that they received in the core Phase 3 study The primary efficacy outcome assessment is a measure of cognition ADAS-Cog 13 Additional measures of global and functional impairments will also be assessed Imaging and biomarkers of AD and neurodegeneration will be measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None