Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355550
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2006-07-20
Brief Title:
Tricaprilin In Age-Associated Memory Impairment
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of Tricaprilin AC-1202 Administered For Ninety Days In Subjects With Age-Associated Memory Impairment
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None