Tricaprilin Phase 3 AD Study

Phase 3

Not yet recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: Placebo; Drug: Tricaprilin

• Registration Number: NCT05809908
• Lead Sponsor: Cerecin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-07
• Last Update Posted: 2024-07-09
• Study Start: 2025-01
• Primary Completion: 2027-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 535

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo formulation, twice daily for 26 weeks, liquid for oral administration
Tricaprilin	Tricaprilin	Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score	26 weeks	The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)	26 weeks	The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with Treatment Related Adverse Events	26 weeks	TEAE incidence rate per treatment group
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score	26 weeks	The ADCS-ADL is a 23-item semi-structured interview with a caregiver and assesses 6 basic activities of daily living and 7 instrumental activities of daily living with a total score of 0 to 78. Lower scores indicate greater severity.