Tricaprilin In Age-Associated Memory Impairment

Phase 2

Completed

• Conditions: Age-Associated Memory Impairment
• Interventions: Other: Placebo; Drug: Tricaprilin

• Registration Number: NCT00355550
• Lead Sponsor: Cerecin

Brief Summary

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.

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-20
• Study First Submitted QC: 2006-07-20
• Study First Posted: 2006-07-24
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching Placebo to AC-1202	Placebo	Placebo formulation, once daily. Administered orally
AC-1202	Tricaprilin	Tricaprilin formulation, once daily. Administered orally

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self-reported memory improvement	90 days

Trial Locations

Locations (5)

Meridien Research; 🇺🇸 Saint Petersburg, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

University Clinical Research-DeLand; 🇺🇸 DeLand, Florida, United States

Anchor Research Center; 🇺🇸 Naples, Florida, United States

University Clinical Research Center; 🇺🇸 Pembroke Pines, Florida, United States