Tricaprilin In Age-Associated Memory Impairment

Age-Associated Memory Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355550
• Other study ID #: KET-06-003
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: June 2007

Study information

• Verified date: September 2020
• Source: Cerecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Age-Associated Memory Impairment
• Memory Disorders

Intervention

Drug:
• Tricaprilin
Powder formulation will be mixed in a liquid (approximately 8 oz).

Other:
• Placebo
Powder formulation will be mixed in a liquid (approximately 8 oz).

Locations

Country	Name	City	State
United States	Meridien Research	Brooksville	Florida
United States	University Clinical Research-DeLand	DeLand	Florida
United States	Anchor Research Center	Naples	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	University Clinical Research Center	Pembroke Pines	Florida
United States	Meridien Research	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cerecin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)		90 days
Primary	Number of subjects with treatment related adverse events	AE incidence rate per treatment group	90 days
Secondary	Self-reported memory improvement		90 days