Alzheimer DiseasePhase 3NCT00056628
COGNIShunt® System for Alzheimer's Disease
A Phase 3 study testing The COGNIShunt® System in people with Alzheimer Disease, run by Eunoe.
Trial 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. Read more about this study
- Who is it for?
- Ages 62 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- The COGNIShunt® System
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Oct 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
About this study
Official title: 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
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.
Read the 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 Alzheimer's 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 Alzheimer's 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 Alzheimer's disease symptoms. This clinical study is designed to determine if this device will stop or slow the progression of Alzheimer's 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 Alzheimer's Disease (NINDS/ADRDA 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 (test/intervention group) or an occluded shunt (control/placebo 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.
- Conditions
- Alzheimer Disease
- Being tested
- The COGNIShunt® System
- Keywords
- Alzheimer disease, Dementia, Ventriculoperitoneal shunt, Tau, ABeta
- Medical subject headings
- Alzheimer Disease, Dementia, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The COGNIShunt® SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2003 (estimated)
- Study startJan 2001
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Eunoe
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dawn McGuire, MD, Chief Scientific Officer, Study director, Eunoe, Inc. 643 Bair Island Road, Redwood City, CA 94063
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056628
- Sponsor's protocol ID
- IA0040
- Other IDs
- Eunoe protocol ID 2000-01, IDE G970117
- Status last verified
- Oct 2004
- First submitted
- 19 Mar 2003
- Last updated
- 12 Sep 2006
- Results posted
- No
Publications
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.
PubMed 12391340Rubenstein 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.
PubMed 9457114Silverberg 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.
PubMed 11723260
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00056628
- Acronym / sponsor ID
- IA0040
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Dementia, Ventriculoperitoneal shunt, Tau, ABeta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- EunoeIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- Oct 2004
- First posted
- 20 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Alzheimer's 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 Alzheimer's 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 Alzheimer's disease symptoms. This clinical study is designed to determine if this device will stop or slow the progression of Alzheimer's 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 Alzheimer's Disease (NINDS/ADRDA 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 (test/intervention group) or an occluded shunt (control/placebo 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 62 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The COGNIShunt® System | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
- Background: PubMed 12391340Silverberg 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.
- Background: PubMed 9457114Rubenstein 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.
- Background: PubMed 11723260Silverberg 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.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn McGuire, MD, Chief Scientific Officer study director
Eunoe, Inc. 643 Bair Island Road, Redwood City, CA 94063
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The COGNIShunt® System in people with Alzheimer Disease, run by Eunoe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056628, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2006.