Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037830
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2002-05-22
Brief Title:
GM1 Ganglioside Effects on Parkinsons Disease
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
The Study of GM1 Ganglioside A Potential New Parkinsons Disease Medication
Status:
COMPLETED
Status Verified Date:
2012-12
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 trial is to examine the short term effects 24 Weeks of GM1 on Parkinsons disease PD symptoms as well as the effects of long-term treatment 120 Weeks with GM1 on disease progression and to examine the extent to which GM1 treatment influences the underlying disease process in PD
Detailed Description:
The study is designed to further examine the extent to which GM1 ganglioside can improve symptoms delay disease progression and perhaps partially restore damaged brain cells in PD patients GM1 ganglioside is a chemical that is normally found in the brain and is a normal part of the outer covering or membrane of nerve cells This study will compare the effectiveness of GM1 to standard PD treatment In addition to studying clinical measures of motor and cognitive functioning the investigators will use PET positron emission tomography scanning to image the brain and the dopamine nerve endings in a subgroup of patients Patients with mild to moderate idiopathic PD will be divided into 2 groups One group will receive GM1 for 24 weeks and the other will receive placebo At the end of this 24 week period all patients will enter into a 96 week treatment period in which all patients will receive GM1
In parallel a group of standard-of-care patients with mild to moderate PD will be monitored over a 1 to 2 year period to assess the natural progression of PD These patients will receive the same clinical evaluations as the treatment group subjects but they will not receive the experimental medication
In parallel a group of standard-of-care patients with mild to moderate PD will be monitored over a 1 to 2 year period to assess the natural progression of PD These patients will receive the same clinical evaluations as the treatment group subjects but they will not receive the experimental medication
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS038681 | NIH | None | httpsreporternihgovquickSearchR01NS038681 |