Tricaprilin In Age-Associated Memory Impairment

Study Overview
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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.

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).

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

Conditions
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Age-Associated Memory Impairment

Intervention / Treatment
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* Drug: Tricaprilin
* Other: Placebo


Participation Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AC-1202<br>Tricaprilin formulation, once daily. Administered orally | Drug: Tricaprilin<br>* Powder formulation will be mixed in a liquid (approximately 8 oz).<br>* Other names: AC-1202;|
| Placebo Comparator: Matching Placebo to AC-1202<br>Placebo formulation, once daily. Administered orally | Other: Placebo<br>* Powder formulation will be mixed in a liquid (approximately 8 oz).<br>* Other names: Matching placebo to AC-1202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test) |  | 90 days | 
| Number of subjects with treatment related adverse events | AE incidence rate per treatment group | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported memory improvement |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, Cognition disorders, nutritional supplement, dietary supplement