At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 84 enrolled
Drug / intervention
ALZ-801drug
Likely dose
ALZ-801 265 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Single-arm Study of the Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease Who Are Carriers of the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)
In Brief
A Phase 2 clinical trial evaluating ALZ-801 for Early Alzheimer's Disease. Completed, enrolled 84 participants across 6 sites in 2 countries.
Detailed Summary
The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Alzheimer's Disease
CountriesCzechia, Netherlands
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedJan 2021
Primary CompletionJun 2023
Study CompletionJul 2025
TodayJul 2026
First PostedJan 5, 2021
Enrollment StartSep 30, 2020
Primary CompletionJun 20, 2023
Study CompletionJul 16, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.5 years ago
Interventions
ALZ-801drug
ALZ-801 265 mg twice daily (BID)