NCT00355550

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Cerecin · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Age-Associated Memory Impairment

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-07-24
• Last updated: 2020-09-18

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study