Tricaprilin Phase 3 AD Study

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, activities of daily living, resource utilisation, safety and tolerability, in subjects with mild to moderately severe probable AD.

This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerecin

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