At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 325 enrolled
Drug / intervention
Experimental: ALZ-801 +1 moredrug
Likely dose
Experimental: 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 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype
In Brief
A Phase 3 clinical trial evaluating Experimental: ALZ-801 and Placebo Comparator: Placebo for Early Alzheimer's Disease. Completed, enrolled 325 participants across 95 sites in 9 countries.
Detailed Summary
This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Alzheimer's Disease
CountriesCanada, Czechia, France, Germany, Iceland, Netherlands, Spain, United Kingdom, United States
CollaboratorsNational Institute on Aging (NIA)
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedFeb 2021
Enrollment StartMay 2021
Primary CompletionMay 2024
Study CompletionJul 2024
TodayJul 2026
First PostedFeb 25, 2021
Enrollment StartMay 19, 2021
Primary CompletionMay 29, 2024
Study CompletionJul 29, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.4 years ago
Interventions
Experimental: ALZ-801drug
ALZ-801 tablet 265 mg once daily in the evening for the first 2 weeks, then ALZ-801 tablet 265 mg BID
Placebo Comparator: Placebodrug
Placebo tablet BID