COGNIShunt® System for Alzheimer's Disease

September 11, 2006 updated by: Eunoe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

250

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

62 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Participants must meet National Institute of Neurological Disorders and Strokes, and Alzheimer's Disease and Related Disorders Association (NINDS/ADRDA) criteria of probable Alzheimer's disease of mild to moderate severity.
  • Age at inclusion into study is between 62 and 85 years. Age at onset of symptoms of Alzheimer's disease must be between 60 and 85 years of age.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunoe

Investigators

  • Study Director: Dawn McGuire, MD, Chief Scientific Officer, Eunoe, Inc. 643 Bair Island Road, Redwood City, CA 94063

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

March 19, 2003

First Submitted That Met QC Criteria

March 19, 2003

First Posted (Estimate)

March 20, 2003

Study Record Updates

Last Update Posted (Estimate)

September 12, 2006

Last Update Submitted That Met QC Criteria

September 11, 2006

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0040
  • Eunoe protocol ID 2000-01
  • IDE G970117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on The COGNIShunt® System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe