Trials / Withdrawn
WithdrawnNCT04187547
A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension
A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease and Who Are Noncarriers of the APOE4 Allele
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Cerecin · Industry
- Sex
- All
- Age
- 50 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tricaprilin | Powder formulation will be mixed with 240 mL water and shaken until fully dispersed. Each dosing unit of AC-SD-03 contains 20 g of the active ingredients (tricaprilin) |
| DRUG | Placebo | Matching placebo to AC-SD-03 will be mixed with 240 mL water and shaken until fully dispersed. |
Timeline
- Start date
- 2022-06-30
- Primary completion
- 2023-12-31
- Completion
- 2024-02-28
- First posted
- 2019-12-05
- Last updated
- 2023-04-14
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04187547. Inclusion in this directory is not an endorsement.