A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease and Who Are Noncarriers of the APOE4 Allele

Cerecin0 sitesJune 30, 2022

ConditionsAlzheimer's Disease

InterventionsTricaprilin Placebo

DrugsTricaprilin Placebo

Overview

Phase: Phase 3
Intervention: Tricaprilin
Conditions: Alzheimer's Disease
Sponsor: Cerecin
Primary Endpoint: Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11). Total Score up to 20-week Treatment
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 30, 2022

End Date

February 28, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cerecin

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects between the ages of 50 and 85 (inclusive) at the time of Screening Visit
•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
•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
•If the current dosage regimen is within the approved dose range.

Exclusion Criteria

•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
•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
•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:
•Acute, sub-acute or chronic haemorrhage.
•Cortical infarct (defined as \> 1.5 cm in diameter).

Arms & Interventions

AC-SD-03

Tricaprilin SD formulation, twice daily. Administered orally

Intervention: Tricaprilin

AC-SD-03P

Placebo formulation, twice daily. Administered orally

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11). Total Score up to 20-week Treatment

Time Frame: 20 weeks

Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog 11) is an 11- item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).

Secondary Outcomes

Number of subjects with treatment related adverse events(20 weeks)
Change From Baseline in Dependence Scale.Total Score up to 20-week Treatment(20 weeks)
Clinical Global Impression of Change(20 weeks)
Change From Baseline in RUD-Lite(20 weeks)
Change From Baseline in Disability Assessment for Dementia(20 weeks)