18 completed, 3 withdrawn, 1 not yet recruiting, 1 terminated. 13 Phase 1, 5 Phase 2, 4 Phase 3, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 11, Terminated 1, Withdrawn 1 |
| Phase 2 | 5 | Completed 4, Withdrawn 1 |
| Phase 3 | 4 | Withdrawn 2, Completed 1, Not yet recruiting 1 |
| Not applicable | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study Tricaprilin, Placebo - Alzheimer Disease | Phase 3 | Not yet recruiting | Cerecin | 535 | 2026-12-01 | 2026-07-01 |
| AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions AC-OLE-01-VA - Alzheimer Disease | Phase 1 | Completed | Cerecin | 18 | 2022-11-14 | 2023-10-18 |
| A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects AC-OLE-01-VA - Alzheimer Disease | Phase 1 | Completed | Cerecin | 45 | 2022-07-14 | 2023-10-17 |
| A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension Tricaprilin, Placebo - Alzheimer's Disease | Phase 3 | Withdrawn | Cerecin | 2022-06-30 | 2023-04-14 | |
| Tricaprilin Infantile Spasms Pilot Study Tricaprilin - Infantile Spasm | Phase 1 | Completed | Cerecin | 8 | 2021-11-01 | 2024-09-19 |
| Tricaprilin Liquid Formulation PK Study AC-1202, AC-OLE-01, AC-OLE-02 - Alzheimer Disease | Phase 1 | Terminated | Cerecin | 71 | 2021-08-31 | 2023-10-17 |
| Tricaprilin Phase 2 Pilot Study in Migraine Tricaprilin, Placebo - Migraine | Phase 2 | Completed | Cerecin | 83 | 2020-12-17 | 2024-02-08 |
| Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production Tricaprilin - Alzheimer Disease | Phase 1 | Completed | Cerecin | 12 | 2020-02-27 | 2020-07-08 |
| Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production Tricaprilin, Placebo - Alzheimer Disease | Phase 1 | Completed | Cerecin | 32 | 2019-08-30 | 2020-07-08 |
| Medical Food Formulation Pharmacokinetic (PK) Study in Medium Chain Triglycerides MCTprocal medical food, Milk/tricaprilin oil blend, AC-1207 - Alzheimer Disease | Phase 1 | Withdrawn | Cerecin | 2019-02-13 | 2018-09-27 | |
| Taste-masking Study for Tricaprilin in Sensory Panelists Tricaprilin - Taste Profile Assessments | Phase 1 | Completed | Cerecin | 9 | 2018-09-10 | 2019-11-06 |
| Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production tricaprilin, standard meal, high-fat meal - Alzheimer Disease | Phase 1 | Completed | Cerecin | 20 | 2018-08-05 | 2019-05-29 |
| Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production AC-1202, AC-SD-01 (50 g), AC-SD-01 (75 g) - Healthy | Phase 1 | Completed | Cerecin | 17 | 2017-03-11 | 2017-06-27 |
| Evaluation of PK of AC-1204 Mixed in Water, AC-1202 Mixed in Water, and AC-1202 Mixed in Ensure® on Ketone Body Production AC-1204 mixed in water, AC-1202 mixed in water, AC-1202 mixed in Ensure® - Healthy | Phase 1 | Completed | Cerecin | 16 | 2016-11-01 | 2017-04-11 |
| Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production Caprylic Triglyceride Oil, AC-1202, Axona - Healthy | Phase 1 | Completed | Cerecin | 20 | 2016-07-01 | 2017-04-11 |
| Evaluation of PK of AC1204 v Caprylic Triglyceride Oil Incl Food Effect on Ketone Body Production AC-1204, caprylic triglyceride oil (standard breakfast), caprylic triglyceride oil (high fat breakfast) - Healthy | Phase 1 | Completed | Cerecin | 16 | 2016-04-01 | 2016-10-28 |
| AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext AC-1204, Placebo - Alzheimer's Disease | Phase 2 / Phase 3 | Completed | Cerecin | 418 | 2013-03-01 | 2021-08-02 |
| Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis Caprylic Triglyceride, Placebo - Relapsing Remitting MS, Secondary Progressive MS | Not applicable | Completed | University of Miami | 124 | 2013-02-01 | 2018-01-25 |
| Retrospective Cohort Study Of The Efficacy Of Axona® (Medium Chain Triglycerides) In Patients With Alzheimer's Disease Alzheimer's Disease | Completed | Cerecin | 55 | 2012-01-01 | 2016-04-18 | |
| Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly Ketasyn - Alzheimer's Disease | Completed | Cerecin | 60 | 2008-04-01 | 2008-10-08 |
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Alzheimer Disease (14) · Ketosis (2) · Cognition Disorders (1) · Cognitive Dysfunction (1) · Migraine Disorders (1) · Multiple Sclerosis (1) · Spasms, Infantile (1)
tricaprylin (14) · AC-1202 (7) · caprylidene (2) · Sunflower Oil (1) · Water (1) · maltodextrin (1)
United States (13) · Australia (6) · Singapore (1)
Colleen Hunsaker, D.O. (2) · Samuel T Henderson, PhD (2) · Carol McKenna (1) · Charles Tomek, MD (1) · Geri Poss, MD (1) · Lauren Costantini, PhD (1) · Leticia Tornes, M.D. (1) · Mildred Farmer, MD (1) · Samuel Henderson, PhD (1) · Thomas Hochadel, Pharm.D. (1)