Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142805
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2005-09-01
Brief Title:
Tricaprilin in Mild to Moderate Alzheimers Disease
Sponsor:
Cerecin
Organization:
Cerecin
Study Overview
Official Title:
Safety Tolerability and Efficacy Study of Tricaprilin AC-1202 Administered for Ninety Days in Subjects With Probable Alzheimers Disease of Mild to Moderate Severity
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 evaluate the safety tolerability and effectiveness of tricaprilin administered once a day for ninety days in subjects with mild to moderate probable Alzheimers disease
Detailed Description:
Substantial scientific evidence has shown that defects in glucose metabolism occur in Alzheimers disease Attempts to compensate for the reduced cerebral metabolic rates in AD have met with some success Treatment of AD patients with high doses of glucose and insulin will raise cognitive scores However this effect is slight and high doses of insulin can have adverse consequences Administration of ketone bodies or their metabolic precursors such as medium chain triglycerides MCTs presents an attractive alternative to glucose and insulin In a preliminary study tricaprilin an MCT demonstrated pharmacological activity and statistically significant efficacy in improving short-term memory and attention performance after a single dose
Participants will be randomized to receive either tricaprilin or a matching placebo administered once a day by mixing powder in a glass of liquid The treatment period will last 90 days followed by a 2-week washout period Each patient will be seen 5 times at screening baseline and post-baseline days 45 90 and 104 The visits will include physical andor neuropsychological examinations electrocardiograms ECGs and laboratory tests
Participants will be randomized to receive either tricaprilin or a matching placebo administered once a day by mixing powder in a glass of liquid The treatment period will last 90 days followed by a 2-week washout period Each patient will be seen 5 times at screening baseline and post-baseline days 45 90 and 104 The visits will include physical andor neuropsychological examinations electrocardiograms ECGs and laboratory tests
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?:
None
Is an FDA AA801 Violation?:
None