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
1 other identifier
interventional
156
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2006
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 20, 2006
CompletedFirst Posted
Study publicly available on registry
July 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedSeptember 18, 2020
September 1, 2020
11 months
July 20, 2006
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Self-reported memory improvement
90 days
Study Arms (2)
AC-1202
ACTIVE COMPARATORTricaprilin formulation, once daily. Administered orally
Matching Placebo to AC-1202
PLACEBO COMPARATORPlacebo formulation, once daily. Administered orally
Interventions
Powder formulation will be mixed in a liquid (approximately 8 oz).
Powder formulation will be mixed in a liquid (approximately 8 oz).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI)
- Drugs that impair cognition
- Psychiatric conditions that may impair cognition (e.g.,depression etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cerecinlead
Study Sites (6)
Meridien Research
Brooksville, Florida, 34613, United States
University Clinical Research-DeLand
DeLand, Florida, 32720, United States
Anchor Research Center
Naples, Florida, 34102, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
University Clinical Research Center
Pembroke Pines, Florida, 33024, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Related Publications (1)
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.
PMID: 15123336BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Samuel Henderson, PhD
Cerecin
- PRINCIPAL INVESTIGATOR
Thomas H. Crook III, PhD
Psychologix, Inc.
- STUDY DIRECTOR
Thomas Hochadel, Pharm.D.
Advanced Research Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2006
First Posted
July 24, 2006
Study Start
July 1, 2006
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
September 18, 2020
Record last verified: 2020-09