Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056628
Status:
COMPLETED
Last Update Posted:
2006-09-12
First Post:
2003-03-19
Brief Title:
COGNIShunt System for Alzheimers Disease
Sponsor:
Eunoe
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Study to Evaluate the Effect of Flow-Regulated Ventriculoperitoneal Shunting on Progression of Alzheimers Disease An Investigation of the Safety and Effectiveness of the COGNIShunt CNS Shunt System
Status:
COMPLETED
Status Verified Date:
2004-10
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:
This is a study of the effect on the progression of Alzheimers Disease of a surgically implanted shunt tube to increase the flow of cerebrospinal fluid and improve the clearance of potential neurotoxins from the fluid bathing the brain
Detailed Description:
Cerebrospinal fluid CSF is the protective fluid that fills the empty spaces around the brain and spinal cord CSF is naturally produced and absorbed but with age abnormal metabolism and clearance of amyloid beta proteins can lead to accumulation of these proteins resulting in plaque formation a leading contributor to the progression of Alzheimers disease AD The shunt treatment is designed to drain CSF with these toxic elements from the skull and allow replenishment of normal CSF This clinical study is designed to determine if this device will stop or slow the progression of Alzheimers disease
The COGNIShunt System is a proprietary device designed to increase the flow of cerebrospinal fluid CSF and improve clearance of putative neurotoxins from the CSF that are believed to contribute to the progression of Alzheimers disease symptoms This clinical study is designed to determine if this device will stop or slow the progression of Alzheimers disease The pivotal study is a prospective randomized double-blinded placebo-controlled trial to evaluate the effect of flow-regulated ventriculoperitoneal CSF drainage with the COGNIShunt system on cognitive and clinical function in approximately 250 participants with Alzheimers Disease NINDSADRDA criteria Study participants will be permitted to continue anti-dementia drug therapy if their drug regime has been stable for 3 months prior to entry This is a two-part study In Part I participants will be randomized to receive either a functioning COGNIShunt System testintervention group or an occluded shunt controlplacebo group The duration of Part I is nine months to be followed by an extension phase of an additional 9 months constituting Part II During Part II subjects with occluded shunts have the opportunity to receive a functioning COGNIShunt so that all study participants may have open devices during Part II The total duration of the study is 18 months Visits to the site include for screening and baseline may be done in one or two visits surgery and a visit the 1st 3rd 6th 9th 12th 15th and 18th month after surgery
The COGNIShunt System is a proprietary device designed to increase the flow of cerebrospinal fluid CSF and improve clearance of putative neurotoxins from the CSF that are believed to contribute to the progression of Alzheimers disease symptoms This clinical study is designed to determine if this device will stop or slow the progression of Alzheimers disease The pivotal study is a prospective randomized double-blinded placebo-controlled trial to evaluate the effect of flow-regulated ventriculoperitoneal CSF drainage with the COGNIShunt system on cognitive and clinical function in approximately 250 participants with Alzheimers Disease NINDSADRDA criteria Study participants will be permitted to continue anti-dementia drug therapy if their drug regime has been stable for 3 months prior to entry This is a two-part study In Part I participants will be randomized to receive either a functioning COGNIShunt System testintervention group or an occluded shunt controlplacebo group The duration of Part I is nine months to be followed by an extension phase of an additional 9 months constituting Part II During Part II subjects with occluded shunts have the opportunity to receive a functioning COGNIShunt so that all study participants may have open devices during Part II The total duration of the study is 18 months Visits to the site include for screening and baseline may be done in one or two visits surgery and a visit the 1st 3rd 6th 9th 12th 15th and 18th month after surgery
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 |
|---|---|---|---|
| IDE G970117 | None | None | None |
| Eunoe protocol ID 2000-01 | None | None | None |