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

Sponsor
Cerecin
Study ID
NCT05809908
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Apr 12, 2023
Start date
Dec 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
535 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tricaprilin
    Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration
  • Placebo Comparator: Placebo
    Placebo formulation, twice daily for 26 weeks, liquid for oral administration

Primary Outcome Measure

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score [ Time Frame: 26 weeks ]

Central Contacts

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