COGNIShunt® System for Alzheimer's Disease
Study to Evaluate the Effect of Flow-Regulated Ventriculoperitoneal Shunting on Progression of Alzheimer's Disease: An Investigation of the Safety and Effectiveness of the COGNIShunt® CNS Shunt System
3 other identifiers
interventional
250
0 countries
N/A
Brief Summary
This is a study of the effect on the progression of Alzheimer's 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 alzheimer-disease
Started Jan 2001
Typical duration for phase_3 alzheimer-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 19, 2003
CompletedFirst Posted
Study publicly available on registry
March 20, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedSeptember 12, 2006
October 1, 2004
March 19, 2003
September 11, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- Family history of early onset Alzheimer's disease.
- History of recent acute myocardial infarction.
- Unstable angina.
- Participants receiving anticoagulants or anti-platelet agents.
- History of malignancy, active systemic infections, clinically significant respiratory dysfunction and/or liver disease.
- History of bleeding disorders, uncontrolled diabetes mellitus and/or hypothyroidism.
- History of stroke.
- Diagnosis of Normal Pressure Hydrocephalus.
- Chronic renal insufficiency.
- History of severe head injury.
- History of alcohol and/or drug abuse.
- Positive FTA, low serum B12.
- Participants exhibiting Parkinsonian signs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eunoelead
Related Publications (3)
Silverberg GD, Levinthal E, Sullivan EV, Bloch DA, Chang SD, Leverenz J, Flitman S, Winn R, Marciano F, Saul T, Huhn S, Mayo M, McGuire D. Assessment of low-flow CSF drainage as a treatment for AD: results of a randomized pilot study. Neurology. 2002 Oct 22;59(8):1139-45. doi: 10.1212/01.wnl.0000031794.42077.a1.
PMID: 12391340BACKGROUNDRubenstein E. Relationship of senescence of cerebrospinal fluid circulatory system to dementias of the aged. Lancet. 1998 Jan 24;351(9098):283-5. doi: 10.1016/S0140-6736(97)09234-9.
PMID: 9457114BACKGROUNDSilverberg GD, Heit G, Huhn S, Jaffe RA, Chang SD, Bronte-Stewart H, Rubenstein E, Possin K, Saul TA. The cerebrospinal fluid production rate is reduced in dementia of the Alzheimer's type. Neurology. 2001 Nov 27;57(10):1763-6. doi: 10.1212/wnl.57.10.1763.
PMID: 11723260BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dawn McGuire, MD, Chief Scientific Officer
Eunoe, Inc. 643 Bair Island Road, Redwood City, CA 94063
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 19, 2003
First Posted
March 20, 2003
Study Start
January 1, 2001
Study Completion
October 1, 2004
Last Updated
September 12, 2006
Record last verified: 2004-10