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

NCT05809908 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: AC-22-027
• Study Type: interventional
• Target: 535
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score

  The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).

  26 weeks

• Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

  The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).

  26 weeks

Secondary Outcomes (2)

• Change From Baseline in a composite score of Category Fluency Test (CFT), Controlled Oral Word Association Test (COWAT), and ADAS-Cog subtests Word Recall, Word Recognition and Orientation

  26 weeks

• Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score

  26 weeks

Other Outcomes (1)

• Exploratory Biomarker Analysis

  26 weeks

Study Arms (2)

Tricaprilin

ACTIVE COMPARATOR

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

Drug: Tricaprilin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tricaprilin DRUG

Each dose of IMP will be administered orally 30 minutes after completing a full meal. There is 1 g of tricaprilin per 2 ml of AC-OLE-01-VA. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of tricaprilin; 80 ml total daily dose of AC-OLE-01-VA, over the course of 2-4 weeks.

Tricaprilin

Placebo DRUG

Each dose of IMP will be administered orally 30 minutes after completing a full meal. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of placebo; 80 ml total daily dose of placebo, over the course of 2-4 weeks.

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cerecin: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

tricaprylin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Study Director

CONTACT

6568132999; clinical@cerecin.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-11