Trial | NCT00355550  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    156
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.
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 Started
Jul 31
2006
Primary Completion
Jun 30
2007
Study Completion
Jun 30
2007
Last Update
Sep 18
2020

Drug Tricaprilin

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

  • Other names: AC-1202

Other Placebo

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

  • Other names: Matching placebo to AC-1202

AC-1202 Active Comparator

Tricaprilin formulation, once daily. Administered orally

Matching Placebo to AC-1202 Placebo Comparator

Placebo formulation, once daily. Administered orally

Criteria 

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.)
No Results Posted