Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202124
Status:
COMPLETED
Last Update Posted:
2005-09-20
First Post:
2005-09-13
Brief Title:
Double Blind Study of Trp01 in Patients With Alzheimers Disease
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Double Blind Medium Term Efficacy Study of Trp01 in Patients With Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2002-11
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 tryptophan is effective in the treatment of mild to moderate Alzheimers Disease AD
Detailed Description:
The clinical trial will be a double-blind placebo-controlled study with patients being randomized in a 21 ratio into groups A and B respectively
Group A TRP01 1g bid for 26 weeks
Group B placebo capsules bid for 26 weeks
After the initial screening clinic visits will take place at 0 13 and 26 weeks The blinding will be maintained until all patients have completed the 26-week trial Any patients wishing to continue taking the medication upon completion of the trial will be provided a prescription for the drug and may purchase it at their own expense
Group A TRP01 1g bid for 26 weeks
Group B placebo capsules bid for 26 weeks
After the initial screening clinic visits will take place at 0 13 and 26 weeks The blinding will be maintained until all patients have completed the 26-week trial Any patients wishing to continue taking the medication upon completion of the trial will be provided a prescription for the drug and may purchase it at their own expense
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None