A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Prob… (NCT04187547) | Clinical Trial Compass
WithdrawnPhase 3
A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension
Stopped: Study replaced with a new study
0Started 2022-06-30
Plain-language summary
This is Phase 3 study, multi-centre, double-blind, placebo controlled, parallel group to evaluate the effects of AC-SD-03 on the efficacy and safety among participants with mild to moderate Alzheimer's Disease.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects between the ages of 50 and 85 (inclusive) at the time of Screening Visit 1. Subjects 86 to 90 years of age (inclusive) can be enrolled, provided that the Medical Monitor reviews the subject's medical condition during the screening process and approves enrolment.
. Dementia of mild to moderate severity, as classified by MMSE score between 14 to 26, inclusive, at Screening Visit 1.
. Meets diagnostic clinical criteria of probable Alzheimer's dementia according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) \[25\].
. Magnetic resonance imaging prior to Visit 3 (Baseline) compatible with a diagnosis of probable AD.
. Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) brain scan showing a pattern typical for AD according to central PET reader (with areas of glucose hypometabolism in posterior cingulate, temporal, parietal, and/or prefrontal cortices, as per criteria in imaging manual).
. Confirmed APOE negative genotype result obtained by the central laboratory prior to Screening Visit 2 or documented prior to screening.
. Subjects taking the following cholinesterase inhibitors (ChEI): donepezil, galantamine, or rivastigmine; and/or GV-971, and/or memantine and/or other agents which may impact cognition (e.g., Souvenaid®, NeuroAidTM, Cerefolin®, Gingko biloba, etc) are eligible for enrolment:
. If the subject has been taking such medication(s)/products for 3 months or more at Screening Visit 1.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11). Total Score up to 20-week Treatment
. Current use or use within 3 months of Visit 3 (Baseline), of Axona® or other MCT-containing products. Use of coconut oil up to 15 mL (1 tablespoon) per day is allowed. Use of MCT-containing products is not allowed at any time during trial participation.
. Use of any other investigational agent within 60 days prior to Screening Visit 1.
. Has a known allergy or hypersensitivity to triglycerides.
. In the opinion of the Investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the subject at risk.
. 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, etc.)
. Has a modified Hachinski Ischemia score greater than (\>) 4 at Screening Visit 2.
. Has a history or clinical laboratory evidence of cerebrovascular disease (stroke, transient ischemic attack, haemorrhage), or diagnosis of possible, probable, or definite vascular dementia at Screening Visit 1 in accordance with National Institute of Neurological Disorders and Stroke criteria.
. Brain MRI performed at Screening (prior to Visit 3) (per centrally read MRI) that shows evidence of any of the following: