Tricaprilin In Age-Associated Memory Impairment

Cerecin

Status and phase: Completed; Phase 2

Conditions: Age-Associated Memory Impairment

Treatments: Other: Placebo; Drug: Tricaprilin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00355550

KET-06-003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 156 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups, including a placebo group

AC-1202

Active Comparator group

Description:

Tricaprilin formulation, once daily. Administered orally

Treatment:

Drug: Tricaprilin

Matching Placebo to AC-1202

Placebo Comparator group

Description:

Placebo formulation, once daily. Administered orally

Treatment:

Other: Placebo