- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion date, Trial primary completion date: Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study (clinicaltrials.gov) - Sep 20, 2024
P3, N=535, Not yet recruiting,
No abstract available Trial completion date: Jan 2028 --> Aug 2028 | Trial primary completion date: Jan 2027 --> Aug 2028
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion, Trial completion date, Trial primary completion date: Tricaprilin Infantile Spasms Pilot Study (clinicaltrials.gov) - Sep 20, 2024
P1, N=8, Completed,
Trial completion date: Jan 2028 --> Aug 2028 | Trial primary completion date: Jan 2027 --> Aug 2028 Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Dec 2023 | Trial primary completion date: Jan 2025 --> Dec 2023
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion date, Trial initiation date, Trial primary completion date: Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study (clinicaltrials.gov) - Feb 15, 2024
P3, N=535, Not yet recruiting,
Results suggest positive directional promise over 2-3 Trial completion date: Jan 2027 --> Jan 2028 | Initiation date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2026 --> Jan 2027
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial termination: Tricaprilin Liquid Formulation PK Study (clinicaltrials.gov) - Oct 17, 2023
P1, N=71, Terminated,
Recruiting --> Completed Recruiting --> Terminated; Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty.
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion, Trial completion date: 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 (clinicaltrials.gov) - Oct 17, 2023
P1, N=45, Completed,
Recruiting --> Terminated; Part 1 was completed, Part 2 and Part 3 of the study were not conducted under this study protocol due to subject recruitment difficulty. Recruiting --> Completed | Trial completion date: Mar 2023 --> Oct 2022
- |||||||||| tricaprilin (AC-1204) / Cerecin
Enrollment closed, Trial completion date, Trial primary completion date: Tricaprilin Infantile Spasms Pilot Study (clinicaltrials.gov) - Jul 27, 2023
P1, N=8, Active, not recruiting,
Recruiting --> Completed | Trial completion date: Mar 2023 --> Oct 2022 Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Jan 2025 | Trial primary completion date: Mar 2023 --> Jan 2025
- |||||||||| tricaprilin (AC-1204) / Cerecin
Journal: Modeling digestion, absorption, and ketogenesis after administration of tricaprilin formulations to humans. (Pubmed Central) - Dec 6, 2022
A partial parameter sensitivity analysis elucidated various influences on the plasma ketone levels that are mainly responsible for the therapeutic effects of tricaprilin. Based on our findings, we concluded that dispersibility and lipolysis of tricaprilin together with the gastric emptying patterns are limiting ketogenesis, while other steps such as the conversion of octanoic acid to ketone bodies play a minor role only.
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion: Tricaprilin Phase 2 Pilot Study in Migraine (clinicaltrials.gov) - Aug 22, 2022
P2, N=83, Completed,
Based on our findings, we concluded that dispersibility and lipolysis of tricaprilin together with the gastric emptying patterns are limiting ketogenesis, while other steps such as the conversion of octanoic acid to ketone bodies play a minor role only. Active, not recruiting --> Completed
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion date, Trial primary completion date: Tricaprilin Infantile Spasms Pilot Study (clinicaltrials.gov) - Mar 10, 2022
P1, N=10, Recruiting,
Not yet recruiting --> Recruiting Trial completion date: Aug 2022 --> Mar 2023 | Trial primary completion date: Aug 2022 --> Mar 2023
- |||||||||| tricaprilin (AC-1204) / Cerecin
Enrollment closed: Tricaprilin Phase 2 Pilot Study in Migraine (clinicaltrials.gov) - Oct 12, 2021
P2, N=100, Active, not recruiting,
Trial completion date: Aug 2022 --> Mar 2023 | Trial primary completion date: Aug 2022 --> Mar 2023 Recruiting --> Active, not recruiting
- |||||||||| tricaprilin (AC-1204) / Cerecin
Enrollment open: Tricaprilin Liquid Formulation PK Study (clinicaltrials.gov) - Oct 7, 2021
P1, N=80, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| tricaprilin (AC-1204) / Cerecin
Enrollment open: Tricaprilin Infantile Spasms Pilot Study (clinicaltrials.gov) - Sep 26, 2021
P1, N=10, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion date, Trial initiation date, Trial primary completion date: Tricaprilin Infantile Spasms Pilot Study (clinicaltrials.gov) - Jun 11, 2021
P1, N=10, Not yet recruiting,
Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Aug 2022 | Initiation date: Apr 2021 --> Aug 2021 | Trial primary completion date: Dec 2021 --> Aug 2022
- |||||||||| tricaprilin (AC-1204) / Cerecin
Enrollment change, Trial completion date, Trial primary completion date: Tricaprilin Phase 2 Pilot Study in Migraine (clinicaltrials.gov) - Jun 9, 2021
P2, N=100, Recruiting,
Trial completion date: Dec 2021 --> Aug 2022 | Initiation date: Apr 2021 --> Aug 2021 | Trial primary completion date: Dec 2021 --> Aug 2022 N=66 --> 100 | Trial completion date: Oct 2021 --> Apr 2022 | Trial primary completion date: Jun 2021 --> Mar 2022
- |||||||||| tricaprilin (AC-1204) / Cerecin
Enrollment open: Tricaprilin Phase 2 Pilot Study in Migraine (clinicaltrials.gov) - Dec 3, 2020
P2, N=54, Recruiting,
Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 Not yet recruiting --> Recruiting
- |||||||||| tricaprilin (AC-1204) / Cerecin
[VIRTUAL] TRICAPRILIN SHOWS SIMILAR PK, SAFETY AND TOLERABILITY IN CAUCASIANS AND ASIANS () - Aug 10, 2020 - Abstract #CTAD2020CTAD_109;
P1
Exposure to total ketones, the active species after tricaprilin administration was no different for healthy ethnic Chinese participants compared to healthy Caucasians. There does not appear to be any ethnic difference in absorption or metabolism of tricaprilin to produce ketone bodies, or in their safety and tolerability profile.
- |||||||||| tricaprilin (AC-1204) / Cerecin
[VIRTUAL] AN EVIDENCE-BASED RISK-MITIGATION APPROACH TO STUDY DESIGN IN APOE4(-) MILD TO MODERATE AD () - Aug 10, 2020 - Abstract #CTAD2020CTAD_108;
P3
Background: AC-SD-03 is a proprietary formulation of tricaprilin, a ketogenic therapy for Alzheimer’s disease (AD)... This Phase 3 study of AC-SD- 03 in APOE4(-) patients with mild to moderate AD has been designed to mitigate risk and ensure success and builds on a firm understanding of the disease in an important subset of patients of AD.
- |||||||||| tricaprilin (AC-1204) / Cerecin
[VIRTUAL] NOVEL FORMULATION AC-SD-03 OF TRICAPRILIN LEADS TO EXCELLENT PK AND SAFETY IN DOSES OF UP TO 30G BID () - Aug 10, 2020 - Abstract #CTAD2020CTAD_107;
P1
This Phase 3 study of AC-SD- 03 in APOE4(-) patients with mild to moderate AD has been designed to mitigate risk and ensure success and builds on a firm understanding of the disease in an important subset of patients of AD. Formulation AC-SD-03 has demonstrated excellent PK, safety and tolerability in young males and in an older healthy population, in doses of up to 30g BID, and will be moved forward into a Phase 3 study in mild to moderate AD.
- |||||||||| tricaprilin (AC-1204) / Cerecin
[VIRTUAL] ADMINISTERING TRICAPRILIN AFTER A MEAL OPTIMISES BIOAVAILABILITY AND MINIMISES ADVERSE EVENTS () - Aug 10, 2020 - Abstract #CTAD2020CTAD_106;
P1
Formulation AC-SD-03 has demonstrated excellent PK, safety and tolerability in young males and in an older healthy population, in doses of up to 30g BID, and will be moved forward into a Phase 3 study in mild to moderate AD. In future clinical studies, tricaprilin will be administered 30’ after completion of a meal to optimise bioavailability and minimise any GI adverse events.
- |||||||||| tricaprilin (AC-1204) / Cerecin
[VIRTUAL] Clinical development of tricaprilin, a ketogenic drug for Alzheimer's disease () - Aug 2, 2020 - Abstract #AAIC2020AAIC_3364;
In future clinical studies, tricaprilin will be administered 30’ after completion of a meal to optimise bioavailability and minimise any GI adverse events. The selected formulation will be moved forward in drug development with an ascending dose study in healthy elderly subjects and a Phase 3 study in mild to moderate Alzheimer's disease.
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion, Trial completion date, Trial primary completion date: Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production (clinicaltrials.gov) - Jul 8, 2020
P1, N=32, Completed,
The selected formulation will be moved forward in drug development with an ascending dose study in healthy elderly subjects and a Phase 3 study in mild to moderate Alzheimer's disease. Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2020 | Trial primary completion date: Aug 2020 --> Apr 2020
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion, Trial completion date, Trial primary completion date: Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production (clinicaltrials.gov) - Jul 7, 2020
P1, N=12, Completed,
Active, not recruiting --> Completed | Trial completion date: Aug 2020 --> May 2020 | Trial primary completion date: Aug 2020 --> Apr 2020 Active, not recruiting --> Completed | Trial completion date: Jul 2020 --> May 2020 | Trial primary completion date: Jun 2020 --> Mar 2020
- |||||||||| tricaprilin (AC-1204) / Cerecin
Trial completion: Taste-masking Study for Tricaprilin in Sensory Panelists (clinicaltrials.gov) - Nov 9, 2019
P1, N=9, Completed,
Trial completion date: Jul 2022 --> Dec 2022 | Initiation date: Apr 2020 --> Jul 2020 | Trial primary completion date: Jun 2022 --> Sep 2022 Active, not recruiting --> Completed
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