Tricaprilin In Age-Associated Memory Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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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

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Age-Associated Memory Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AC-1202

Tricaprilin formulation, once daily. Administered orally

Group Type ACTIVE_COMPARATOR

Tricaprilin

Intervention Type DRUG

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

Matching Placebo to AC-1202

Placebo formulation, once daily. Administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Tricaprilin

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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AC-1202 Matching placebo to AC-1202

Eligibility Criteria

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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.)

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No