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Tricaprilin In Age-Associated Memory Impairment

Primary Purpose

Age-Associated Memory Impairment

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tricaprilin
Placebo
Sponsored by
Cerecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Associated Memory Impairment focused on measuring Mild Cognitive Impairment, Cognition disorders, nutritional supplement, dietary supplement

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • Meridien Research
  • University Clinical Research-DeLand
  • Anchor Research Center
  • Renstar Medical Research
  • University Clinical Research Center
  • Meridien Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AC-1202

Matching Placebo to AC-1202

Arm Description

Tricaprilin formulation, once daily. Administered orally

Placebo formulation, once daily. Administered orally

Outcomes

Primary Outcome Measures

Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)
Number of subjects with treatment related adverse events
AE incidence rate per treatment group

Secondary Outcome Measures

Self-reported memory improvement

Full Information

First Posted
July 20, 2006
Last Updated
September 16, 2020
Sponsor
Cerecin
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1. Study Identification

Unique Protocol Identification Number
NCT00355550
Brief Title
Tricaprilin In Age-Associated Memory Impairment
Official Title
A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerecin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Associated Memory Impairment
Keywords
Mild Cognitive Impairment, Cognition disorders, nutritional supplement, dietary supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC-1202
Arm Type
Active Comparator
Arm Description
Tricaprilin formulation, once daily. Administered orally
Arm Title
Matching Placebo to AC-1202
Arm Type
Placebo Comparator
Arm Description
Placebo formulation, once daily. Administered orally
Intervention Type
Drug
Intervention Name(s)
Tricaprilin
Other Intervention Name(s)
AC-1202
Intervention Description
Powder formulation will be mixed in a liquid (approximately 8 oz).
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo to AC-1202
Intervention Description
Powder formulation will be mixed in a liquid (approximately 8 oz).
Primary Outcome Measure Information:
Title
Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)
Time Frame
90 days
Title
Number of subjects with treatment related adverse events
Description
AE incidence rate per treatment group
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Self-reported memory improvement
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Henderson, PhD
Organizational Affiliation
Cerecin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas H. Crook III, PhD
Organizational Affiliation
Psychologix, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Hochadel, Pharm.D.
Organizational Affiliation
Advanced Research Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
University Clinical Research-DeLand
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
University Clinical Research Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15123336
Citation
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. doi: 10.1016/S0197-4580(03)00087-3.
Results Reference
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Tricaprilin In Age-Associated Memory Impairment

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