Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study

Launched by CERECIN · Mar 30, 2023

Keywords

ClinConnect Summary

The Tricaprilin Phase 3 ALTER-AD Study is a clinical trial designed to test how well a medication called tricaprilin works for people with mild to moderate Alzheimer's disease. The study will look at how this medication affects thinking abilities, daily activities, and overall safety. Participants will take 20 grams of tricaprilin twice a day, and the trial will include up to 535 people from various locations.

To be eligible for this study, participants should have a Mini Mental State Exam score between 14 to 24, which helps to measure their cognitive function, and must have a diagnosis of Alzheimer's disease. They should also be currently taking certain medications for Alzheimer's, such as donepezil, galantamine, or memantine. However, those who have used medium chain triglyceride products recently, have not completed six years of formal education, or have other medical conditions that could cause dementia may not qualify. This study is not yet recruiting, but it aims to provide valuable information on how tricaprilin could help improve the lives of those affected by Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Mini Mental State Exam (MMSE) score between 14 to 24
• • Meets diagnostic clinical criteria of probable Alzheimer's dementia according to the NIA-AA criteria
• • Magnetic resonance imaging (MRI) compatible with a diagnosis of probable AD according to central MRI reader.
• • Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or memantine
• Key Exclusion Criteria:
• • Current use or use within 3 months of Visit 3 (Baseline), of medium chain triglyceride -containing products.
• • Completed less than 6 years of formal education.
• • Has any medical or neurological condition, other than AD, that could explain the subject's dementia (e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia)
• • Has a modified Hachinski Ischaemia score \> 4