Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-85
SponsorCerecin

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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's disease), GI bleed (upper or lower), or peptic ulcer disease; any of these conditions are exclusionary, if active in the past 5 years. Participants with remote quiescent disease, at the Investigators discretion , are not excluded; b) Participants with current or a history of (within the last 5 years) any of the following conditions are excluded: clinically significant reflux disease (e.g., Barrett's oesophagus, stricture, ulcer, haemorrhage), or severe gastroesophageal reflux disease that, in the opinion of the Investigator, is not well-controlled by medication; c) Irritable bowel syndrome, diverticular disease (e.g., diverticulosis, or diverticulitis), or chronic gastritis; any of these conditions are exclusionary if there has been an acute event within 1 year prior to Screening; d) History of gastric food intolerance, whether it be allergy or chronic oversensitivity, or a history of stomach upset reaction to a variety of foods

Current or previous treatment with any anti-amyloid or anti-Tau antibodies such as lecanemab and donanemab within 6 months prior to the day of screening

Trial design

Treatments tested in this trial

  • Tricaprilin
  • Placebo

Treatment groups

535 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators