Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099710
Status:
COMPLETED
Last Update Posted:
2009-12-03
First Post:
2004-12-17
Brief Title:
Curcumin in Patients With Mild to Moderate Alzheimers Disease
Sponsor:
John Douglas French Foundation
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Phase II Double-Blind Placebo-Controlled Study of the Safety and Tolerability of Two Doses of Curcumin C3 Complex Versus Placebo in Patients With Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2009-12
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 examine the safety and tolerability of curcumin and to determine its effect on patients with mild to moderate Alzheimers Disease AD
Detailed Description:
Curcumin a yellow substance found in the spice Turmeric has antioxidant non-steroidal anti-inflammatory NSAID and cholesterol-lowering properties all of which make it a good candidate in the prevention and treatment of AD The study will examine the safety and tolerability of 2 different doses of curcumin C3 complex Blood and cerebrospinal fluid CSF tests will be used to examine how the curcumin is absorbed in the body and whether it has an effect on inflammation oxidative damage and cholesterol levels Participants will also be tested to determine the potential effect of curcumin on cognition behavior and daily function in patients with mild to moderate AD
Participants will be randomly assigned to receive one of two doses of curcumin or a placebo for the initial 6 months of the trial For the final 6 months those receiving a placebo will be switched to one of the two doses of the drug The 33 participants will make 7 visits to the study site over a 12-month period These visits may include a physical and neurological examination routine laboratory tests lumbar puncture and neuropsychological mood and memory evaluations
Participants will be randomly assigned to receive one of two doses of curcumin or a placebo for the initial 6 months of the trial For the final 6 months those receiving a placebo will be switched to one of the two doses of the drug The 33 participants will make 7 visits to the study site over a 12-month period These visits may include a physical and neurological examination routine laboratory tests lumbar puncture and neuropsychological mood and memory evaluations
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