Table of contents
Trial overview
The available trial is studying 5-[(1R,5R)-3-AZABICYCLO[3.1.0]HEXAN-1-YL]-3-METHYL-1,2,4-OXADIAZOLE in people with hallucinations and delusions associated with Alzheimer’s disease psychosis.[1]
The study title says it is evaluating ML-007C-MA for this condition, and the listed intervention includes placebo for ML-007C-MA bilayer tablet and 5-[(1R,5R)-3-AZABICYCLO[3.1.0]HEXAN-1-YL]-3-METHYL-1,2,4-OXADIAZOLE given by mouth.[1]
This is an interventional study, which means researchers give a treatment and compare outcomes between groups.[1]
Study design and phase
The trial is in Phase 2.[1]
Phase 2 studies are used to look more closely at whether a treatment may help and to continue checking safety and response in the target group.[1]
The study status is Authorised, and the planned enrollment is 300 participants.[1]
Who can participate
The target population is adults with hallucinations and delusions associated with Alzheimer’s disease psychosis.[1]
The source data do not list more detailed entry rules, such as age limits, test results, or other health requirements.[1]
What is being measured
The main endpoint is the NPI-C H+D score, which is a rating used to measure hallucinations and delusions.[1]
Researchers will measure the change from baseline to Week 7, so they are looking at how symptoms change from the start of the study to the seventh week.[1]
The brief summary says the goal is to evaluate the efficacy of ML-007C-MA compared with placebo for hallucinations and delusions associated with ADP as measured by the NPI-C H+D score.[1]
Trial summary
In simple terms, this study asks whether 5-[(1R,5R)-3-AZABICYCLO[3.1.0]HEXAN-1-YL]-3-METHYL-1,2,4-OXADIAZOLE, as part of ML-007C-MA, can improve hallucinations and delusions in Alzheimer’s disease psychosis better than placebo.[1]
The trial is focused on symptom change over 7 weeks, and it plans to include 300 people.[1]
Because only one trial is provided, the current evidence summary is limited to this Phase 2 study in people with Alzheimer’s disease psychosis.[1]
