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Completed

NCT Number: NCT00355550

Tricaprilin In 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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Meridien Research, Brooksville, Florida, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Tricaprilin

Drug

Powder formulation will be mixed in a liquid (approximately 8 oz).

Other names: AC-1202

Placebo

Other

Powder formulation will be mixed in a liquid (approximately 8 oz).

Other names: Matching placebo to AC-1202

Primary outcomes

  1. Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)

    Time frame: 90 days

  2. Number of subjects with treatment related adverse events

    Time frame: 90 days

    AE incidence rate per treatment group

Secondary outcomes

  1. Self-reported memory improvement

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Cerecin

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 24, 2006
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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