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A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension

NCT04187547 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cerecin

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-12-31
Completion
2024-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187547 on ClinicalTrials.gov