COGNIShunt® System for Alzheimer's Disease

NCT ID: NCT00056628

Last Updated: 2006-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2004-10-31

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.

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

Keywords

Alzheimer disease; Dementia; Ventriculoperitoneal shunt; Tau; ABeta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

The COGNIShunt® System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participants must have no systemic or other brain diseases that could explain deficits in memory or cognition.
• Imaging studies must be consistent with a diagnosis of Alzheimer's disease.
• Hachinski Ischemic Rating Scale score of 4 or less.
• Participants must have sufficient visual and auditory acuity and verbal communication skills to read and hear the testing materials and respond to questions.
• Participants must be able to read and speak English.
• Participants must have a responsible caregiver/informant willing to participate in the study.
• Use of anti-dementia drugs is permitted if participants have been on a stable dose for at least 3 months prior to enrollment.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 62 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunoe

INDUSTRY

Sponsor Role: lead

Principal Investigators

Dawn McGuire, MD, Chief Scientific Officer

Role: STUDY_DIRECTOR

Eunoe, Inc. 643 Bair Island Road, Redwood City, CA 94063

References

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.

Reference Type: BACKGROUND

PMID: 12391340 (View on PubMed)

Rubenstein 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.

Reference Type: BACKGROUND

PMID: 9457114 (View on PubMed)

Silverberg 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.

Reference Type: BACKGROUND

PMID: 11723260 (View on PubMed)

Other Identifiers

Eunoe protocol ID 2000-01

Identifier Type: -

Identifier Source: secondary_id

IDE G970117

Identifier Type: -

Identifier Source: secondary_id

IA0040

Identifier Type: -

Identifier Source: org_study_id