Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study
535 participantsStarted 2026-06
Plain-language summary
The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia.
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.
Who can participate
Age range55 Years – 85 Years
SexALL
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Key Inclusion Criteria:
* Mini Mental State Exam (MMSE) score between 14 to 24
* Meets diagnostic clinical criteria of probable Alzheimer's disease dementia according to the NIA-AA criteria
* Magnetic resonance imaging (MRI) scan less than 12 months before Baseline compatible with a diagnosis of probable AD
* Plasma biomarker result supporting a diagnosis of AD before Baseline (Aβ42/40 and/or pTau217)
* Confirmed APOE4 genotype result prior to Baseline
* Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or sodium oligomannate (GV-971), and/or memantine, and/or GLP-1 antagonist and/or other agents which may impact cognition are eligible for enrolment: a) If the participant has been taking such medication(s)/products for 3 months or more at Screening Visit 1; b) If the current dosage regimen is within the approved dose range; c) The daily dose has remained unchanged for at least 6 weeks prior to screening; d) If the dose is not expected to change during study participation
Key Exclusion Criteria:
* Has any medical/neurological/psychiatric condition, other than AD, that could explain the participant's dementia or cognitive impairment, such as but not limited to e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, current major depressive episode
* The following GI conditions are exclusionary: a) Inflammatory bowel disease (e.g., ulcerative colitis or Crohn…
What they're measuring
1
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score
Timeframe: 26 weeks
2
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)