AC-OLE-01-VA for Alzheimer Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Quotient Sciences Miami, Miami, FL
Alzheimer Disease
AC-OLE-01-VA - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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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. AC-OLE-01-VA is a treatment for Alzheimer Disease that is free of charge. There is no placebo group in this trial. This treatment has previously been approved by the FDA for a different condition.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alzheimer Disease

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Baseline to 28 days

Hour 8
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)
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)
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)
Baseline to 28 days
Incidence of Treatment Emergent Adverse Events (Part B)
Baseline to 8 days
Incidence of Treatment Emergent Adverse Events (Part A)

Trial Safety

Safety Progress

1 of 3

Other trials for Alzheimer Disease

Trial Design

2 Treatment Groups

Part A - Food Effect Assessment
1 of 2
Part B - Titration Tolerability
1 of 2
Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: AC-OLE-01-VA · No Placebo Group · Phase 1

Part A - Food Effect Assessment
Drug
Experimental Group · 1 Intervention: AC-OLE-01-VA · Intervention Types: Drug
Part B - Titration Tolerability
Drug
Experimental Group · 1 Intervention: AC-OLE-01-VA · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 28 days
Closest Location: Quotient Sciences Miami · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
2020First Recorded Clinical Trial
1 TrialsResearching Alzheimer Disease
3 CompletedClinical Trials

Who is running the clinical trial?

CerecinLead Sponsor
20 Previous Clinical Trials
1,624 Total Patients Enrolled
11 Trials studying Alzheimer Disease
1,173 Patients Enrolled for Alzheimer Disease
Study DirectorStudy DirectorCerecin
1,039 Previous Clinical Trials
479,139 Total Patients Enrolled
8 Trials studying Alzheimer Disease
1,595 Patients Enrolled for Alzheimer Disease

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age, non-pregnant, non-lactating, and weigh at least 55 kg.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.