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

No Placebo-Only Group

Summary

This trial is testing a new liquid form of tricaprilin, a type of fat. The study aims to see how this liquid fat behaves in the body and if it is safe and well-tolerated. Tricaprilin is known for being quickly converted into energy by the body.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 28 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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