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NCT04187547
A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension
Phase 3 trial testing Tricaprilin in Alzheimer's Disease. Withdrawn.
31 December 2023
Quick facts
| Lead sponsor | Cerecin |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 30 June 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 28 February 2024 |
Drugs / interventions tested
- Tricaprilin — full drug profile →
- Placebo
Conditions studied
- Alzheimer's Disease — all drugs for Alzheimer's Disease →
Sponsor
Cerecin — full company profile →
Who can join
Adults 50 to 90, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is Phase 3 study, multi-centre, double-blind, placebo controlled, parallel group to evaluate the effects of AC-SD-03 on the efficacy and safety among participants with mild to moderate Alzheimer's Disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295 -
Alzheimer's disease drug development pipeline: 2020.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050 -
Alzheimer's disease drug development pipeline: 2023.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385 -
Alzheimer's disease drug development pipeline: 2021.
Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179 -
Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970 -
Astrocytes as Key Regulators of Brain Energy Metabolism: New Therapeutic Perspectives.
Beard E, Lengacher S, Dias S, Magistretti PJ, et al · · 2021 · cited 186× · PMID 35087428 · DOI 10.3389/fphys.2021.825816 -
Clinical trials of new drugs for Alzheimer disease: a 2020-2023 update.
Huang LK, Kuan YC, Lin HW, Hu CJ. · · 2023 · cited 165× · PMID 37784171 · DOI 10.1186/s12929-023-00976-6 -
Glutamate and GABA in Microglia-Neuron Cross-Talk in Alzheimer's Disease.
Czapski GA, Strosznajder JB. · · 2021 · cited 125× · PMID 34769106 · DOI 10.3390/ijms222111677
Verify or expand the search:
- PubMed search for NCT04187547
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04268953 — Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production · Phase 1 · completed
- NCT03971123 — Study to Compare the Pharmacokinetics of Tricaprilin Formulations and a Placebo on Ketone Body Production · Phase 1 · completed
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Currently open trials in the same condition.
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- NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease · Phase 1 · recruiting
- NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease · Phase 2 · recruiting
Other Cerecin trials
Trials by the same sponsor.
- NCT05628636 — AC-OLE-01-VA Tolerability Study in Healthy Participants Under Different Dosing Conditions · Phase 1 · completed
- NCT05408780 — A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation · Phase 1 · completed
- NCT04727970 — Tricaprilin Infantile Spasms Pilot Study · Phase 1 · completed
- NCT05028114 — Tricaprilin Liquid Formulation PK Study · Phase 1 · terminated
- NCT04437199 — Tricaprilin Phase 2 Pilot Study in Migraine · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04187547 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cerecin
- Last refreshed: 14 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04187547.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing