At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 95 enrolled
Drug / intervention
AMX0035 +1 moredrug
Likely dose
Not stated in 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.
Phase II Study to Assess the Safety, Tolerability, and Target Engagement of AMX0035, a Fixed Combination of Sodium Phenylbutyrate and Tauroursodeoxycholic Acid for the Treatment of Alzheimer's Disease
In Brief
A Phase 2 clinical trial evaluating AMX0035 and Placebo for Alzheimer Disease. Completed, enrolled 95 participants across 11 sites.
Detailed Summary
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
CollaboratorsAlzheimer's Drug Discovery Foundation, Alzheimer's Association
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartSep 2018
Primary CompletionOct 2020
Study CompletionNov 2020
TodayJul 2026
First PostedMay 23, 2018
Enrollment StartSep 14, 2018
Primary CompletionOct 22, 2020
Study CompletionNov 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.1 years ago
Interventions
AMX0035drug
Combination Therapy of PB and TURSO
Placebodrug
Placebo