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

Cerecin

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: Tricaprilin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05809908

AC-22-027

Details and patient eligibility

About

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.

Enrollment: 535 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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'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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

535 participants in 2 patient groups, including a placebo group

Tricaprilin

Active Comparator group

Description:

Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration

Treatment:

Drug: Tricaprilin

Placebo

Placebo Comparator group

Description:

Placebo formulation, twice daily for 26 weeks, liquid for oral administration

Treatment:

Drug: Placebo