Tricaprilin Phase 3 AD Study

Alzheimer Disease Clinical Trial

Official title:

A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05809908
• Other study ID #: AC-22-027
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2025
• Est. completion date: January 2028

Study information

• Verified date: February 2024
• Source: Cerecin
• Contact: Study Director
• Phone: +65 6813 2999
• Email: clinical[@]cerecin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 535
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Tricaprilin
Each dose of IMP will be administered orally 30 minutes after completing a meal. There is 1 g of tricaprilin per 2 ml of AC-OLE-01-VA. Subjects will titrate from 5 g twice a day to 20 g twice a day, 40 g total daily dose of tricaprilin; 80 ml total daily dose of AC-OLE-01-VA, over the course of 3 weeks.
• Placebo
Each dose of IMP will be administered orally 30 minutes after completing a meal. Subjects will titrate from 5 g twice a day to 20 g twice a day, 40 g total daily dose of safflower oil; 80 ml total daily dose of placebo, over the course of 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score	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).	26 weeks
Primary	Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)	The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).	26 weeks
Secondary	Number of Subjects with Treatment Related Adverse Events	TEAE incidence rate per treatment group	26 weeks
Secondary	Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score	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.	26 weeks