NCT03533257Phase 2Completed

Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease

Study sponsor: Amylyx Pharmaceuticals Inc. · AMLX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-10-22Actual

Enrollment · participants95Actual

Source updated2025-03-07Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Alzheimer Disease

Treatments or interventions studied

AMX0035DrugAlso known as Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO; also known as Tauroursodeoxycholic Acid [TUDCA])
PlaceboDrugAlso known as Comparator

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Treatment-Emergent Adverse Event (TEAEs); description: Comparison between the AMX0035 Group and Placebo of the number of participants with TEAEs; timeFrame: From first dose to 24 weeks; measure: Effect of Treatment on a Global Composite Statistical Test of Cognition, Function, and Neuroanatomy (GST); description: Change from Baseline in GST (global statistical test combining three measures relevant to disease trajectory (cognition \[MADCOMS: Mild/Moderate Alzheimer's Disease Composite Score\], function \[FAQ: Functional Activities Questionnaire\], and total hippocampal volume on magnetic resonance imaging)) for AMX0035 relative to placebo. For MADCOMS and FAQ, a higher score indicates a worse outcome. A larger hippocampal volume is better, so it was reversed before being normalized. Each of the three were normalized against respective baseline means and standard deviations. The mean of the three normalized scores is the final GST. A higher GST score indicates a worse outcome. Standard deviations above the mean are worse; standard deviations below the mean are better. The expected value of the GST at baseline is 0 because it is the mean of three z-scores whose expected values at baseline are 0. AD is multifaceted and the GST was designed to be sensitive to changes in multiple dimensions.; timeFrame: 24 weeks

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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