Clinical trial NCT00355550: Tricaprilin In Age-Associated Memory Impairment
Official title: A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Associated Memory Impairment
Keywords: Mild Cognitive Impairment
Cognition disorders
nutritional supplement
dietary supplement
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2006-07-24
Enrollment: 156
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.)

Primary outcomes:
measure: Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)
timeFrame: 90 days
measure: Number of subjects with treatment related adverse events
timeFrame: 90 days
Secondary outcomes:
measure: Self-reported memory improvement
timeFrame: 90 days
Other outcomes:
Locations:
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: DeLand
country: United States
facility: University Clinical Research-DeLand
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
Study officials:
affiliation: Cerecin
name: Samuel Henderson, PhD
role: STUDY_CHAIR
affiliation: Psychologix, Inc.
name: Thomas H. Crook III, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Research Corporation
name: Thomas Hochadel, Pharm.D.
role: STUDY_DIRECTOR
References:
citation: 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.