Back to resultsTricaprilin Phase 3 AD Study
Primary Purpose
Alzheimer Disease
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tricaprilin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tricaprilin
Placebo
Arm Description
Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration
Placebo formulation, twice daily for 26 weeks, liquid for oral administration
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Number of Subjects with Treatment Related Adverse Events
TEAE incidence rate per treatment group
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05809908
Brief Title
Tricaprilin Phase 3 AD Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerecin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
535 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tricaprilin
Arm Type
Active Comparator
Arm Description
Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo formulation, twice daily for 26 weeks, liquid for oral administration
Intervention Type
Drug
Intervention Name(s)
Tricaprilin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score
Description
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).
Time Frame
26 weeks
Title
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Description
The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Number of Subjects with Treatment Related Adverse Events
Description
TEAE incidence rate per treatment group
Time Frame
26 weeks
Title
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
Description
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.
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
+65 6813 2999
Email
clinical@cerecin.com
12. IPD Sharing Statement
Learn more about this trial
Tricaprilin Phase 3 AD Study
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