NCT05809908

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

A Phase 3, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-OLE-01-VA in Participants With Mild to Moderate Alzheimer's Disease Dementia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 535 (estimated)
• Sponsor: Cerecin · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia. This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Tricaprilin	Each dose of IMP will be administered orally 30 minutes after completing a full meal. There is 1 g of tricaprilin per 2 ml of AC-OLE-01-VA. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of tricaprilin; 80 ml total daily dose of AC-OLE-01-VA, over the course of 2-4 weeks.
DRUG	Placebo	Each dose of IMP will be administered orally 30 minutes after completing a full meal. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of placebo; 80 ml total daily dose of placebo, over the course of 2-4 weeks.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-12-01
• Completion: 2029-01-01
• First posted: 2023-04-12
• Last updated: 2025-11-25

Regulatory

• FDA-regulated drug study