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Lipid Emulsion

AC-OLE-01-VA for Alzheimer's Disease

Phase 1
Waitlist Available
Research Sponsored by Cerecin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 days
Awards & highlights

Study Summary

This trial will study how safe and well-tolerated a new liquid formulation of tricaprilin is, as well as how it is metabolized by the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A)
Incidence of Treatment Emergent Adverse Events (Part B)
Secondary outcome measures
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)
Incidence of Treatment Emergent Adverse Events (Part A)
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B - Titration TolerabilityExperimental Treatment1 Intervention
Subjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch. Participants will be randomised to either study drug or the matching placebo.
Group II: Part A - Food Effect AssessmentExperimental Treatment1 Intervention
Subjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AC-OLE-01-VA
2022
Completed Phase 1
~70

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CerecinLead Sponsor
22 Previous Clinical Trials
1,822 Total Patients Enrolled
Study DirectorStudy DirectorCerecin
1,207 Previous Clinical Trials
489,635 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cumulative population taking part in this clinical experiment?

"Affirmative. Clinicaltrials.gov has evidence that this research initiative, which was first published on July 14th 2022, is actively recruiting participants. Forty-five individuals need to be recruited from a single medical centre."

Answered by AI

For whom is this medical experiment available?

"This study seeks to enroll 45 participants with Alzheimer's disease, aged between 18 and 55."

Answered by AI

Is enrollment still ongoing for this research project?

"As per the information hosted on clinicaltrials.gov, this study is currently open to applicants. It was first made available on July 14th 2022 and has had a recent edit as of July 18th 2022."

Answered by AI

Has the AC-OLE-01-VA treatment been sanctioned by the FDA?

"AC-OLE-01-VA's safety is rated a 1, as this phase 1 trial has only limited evidence of its efficacy and protective effects."

Answered by AI

Does this research program accept applicants over the age of fifty?

"Participants in this medical trial must be older than 18 and younger than 55 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2022. "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. https://clinicaltrials.gov/ct2/show/NCT05408780.
~16 spots leftby Apr 2025
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