Tricaprilin In Age-Associated Memory Impairment

A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment

The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.

Study Overview

• Status: Completed
• Conditions: Age-Associated Memory Impairment
• Intervention / Treatment: Drug: Tricaprilin; Other: Placebo

Detailed Description

One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders.

Study participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Brooksville, Florida, United States, 34613
      • Meridien Research
    • DeLand, Florida, United States, 32720
      • University Clinical Research-Deland
    • Naples, Florida, United States, 34102
      • Anchor Research Center
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research Center
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Complaints that memory has declined since young adult life
• Scores on standardized tests that are at least one standard deviation below the mean score of young adults

Exclusion Criteria:

• Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI)
• Drugs that impair cognition
• Psychiatric conditions that may impair cognition (e.g.,depression etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AC-1202; Tricaprilin formulation, once daily. Administered orally	Drug: Tricaprilin; Powder formulation will be mixed in a liquid (approximately 8 oz).; Other Names: AC-1202
Placebo Comparator: Matching Placebo to AC-1202; Placebo formulation, once daily. Administered orally	Other: Placebo; Powder formulation will be mixed in a liquid (approximately 8 oz).; Other Names: Matching placebo to AC-1202

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)		90 days
Number of subjects with treatment related adverse events	AE incidence rate per treatment group	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Self-reported memory improvement	90 days

Collaborators and Investigators

• Sponsor: Cerecin
• Investigators: Study Chair: Samuel Henderson, PhD, Cerecin; Principal Investigator: Thomas H. Crook III, PhD, Psychologix, Inc.; Study Director: Thomas Hochadel, Pharm.D., Advanced Research Corporation

Publications and helpful links

General Publications

• Reger MA, Henderson ST, Hale C, Cholerton B, Baker LD, Watson GS, Hyde K, Chapman D, Craft S. Effects of beta-hydroxybutyrate on cognition in memory-impaired adults. Neurobiol Aging. 2004 Mar;25(3):311-4. doi: 10.1016/S0197-4580(03)00087-3.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: July 20, 2006
• First Submitted That Met QC Criteria: July 20, 2006
• First Posted (Estimate): July 24, 2006

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; dietary supplement; nutritional supplement; Cognition disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: KET-06-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No