RESEARCH: Study of New Device-Based Treatment for Alzheimer's Disease

[Guest guest]

http://www.ec-online.net/Knowledge/Newsletters/beacon101502.htm

Study of New Device-Based Treatment for Alzheimer’s Disease

An institute near you is investigating a device based treatment for

Alzheimer’s Disease.

Alzheimer’s Disease is the primary cause of senile dementia, affecting more

than 4.5 million US citizens. Advancing age is the key risk factor for

Alzheimer’s Disease. Unprecedented growth in the aging population will

increase the number of individuals afflicted with the disease for which

there is no known disease-modifying agent or cure. Once the disease

develops, the remaining life span of an Alzheimer’s sufferer is generally

reduced by a third. Progressive memory loss and changes in personality

occur early on. As the disease progresses, the patient becomes immobile and

dysfunctional, requiring increasing levels of care. Several drugs, such as

Aricept, Reminyl and Exelon, are currently marketed for the treatment of AD

symptoms. About one out of three patients respond and can tolerate the side

effects of these treatments. In such patients, these drugs can provide

symptomatic benefit, but generally only for 6 to 9 months.

Many avenues are being explored to find new treatments for this debilitating

disease. One approach, being pioneered by the biotechnology company Eunoe,

Inc, looks at helping the body restore its own healing properties. The

nervous system normally produces cerebrospinal fluid (CSF) that bathes the

brain, clears products of brain cell metabolism and provides the optimal

environment for brain cell function. In normal aging, CSF production

declines. In Alzheimer’s Disease patients, changes of normal aging may be

worsened by amyloid deposition in the cells that produce and clear CSF,

leading to marked CSF stagnation. The hypothesis is that impaired clearance

and/or diminished production of CSF leads to stagnation of CSF, resulting in

accumulation of toxic proteins and inflammatory mediators in the brain. Such

accumulated substances play a key role in ongoing brain injury in Alzheimer’

s Disease.

The COGNIShuntÒ System, a flow-controlled shunt being developed by Eunoe,

Inc., was designed to increase flow of CSF and improve clearance of

potential neurotoxins from the fluid bathing the brain without causing

overdrainage of CSF. The placement of this shunt provides a new way for CSF

to flow out of the brain’s fluid-filled cavities (ventricles) and into the

abdomen, where blood vessels absorb the fluid. Since the brain continuously

generates fresh, toxin-free CSF, the placement of this drainage system

should decrease the level of toxins in the fluid bathing the brain, while

allowing increased circulation of fresh, toxin-free, CSF. Decreasing the

toxins that may damage nerve cells in the brain may slow or stop the mental

decline associated with Alzheimer’s Disease.

Although this is a novel, investigative approach to treating Alzheimer’s

disease, the surgical procedure called shunting is a common procedure,

having been used successfully by neurosurgeons since the 1950’s to treat

other conditions such as hydrocephalus (excess fluid around the brain).

Every year, approximately 100,000 shunts are placed or revised in

hydrocephalus patients.

Data from a Eunoe, Inc. pilot feasibility study in 29 patients with mild to

moderate Alzheimer’s Disease, conducted under an FDA-granted Investigational

Device Exemption, indicate that the procedure and COGNIShunt System are well

tolerated in Alzheimer’s patients. The data from this feasibility study

also show a substantial difference in mental function over time, with better

preservation of mental ability in shunted patients versus the control group.

In addition, CSF levels of the potentially neurotoxic proteins found in

Alzheimer’s brain lesions, such as Tau and Amyloid, declined in shunted

patients and remained lower than their initial levels, even after twelve

months.

Based on the encouraging results of the feasibility study, Eunoe, Inc.

initiated a pivotal clinical trial that involves 25 sites throughout the

U.S. Those eligible to participate in the study must:

Have been diagnosed as having Alzheimer’ Disease

Be between 62 and 85 years old

Be a suitable candidate for surgical shunt implantation

Be able to read, speak, and understand English

Have a caregiver available to assist the subject in study participation and

to participate in some evaluations (questionnaires)

Otherwise be in good health

Patients with onset of Alzheimer’s Disease before age 60, family history of

early onset of Alzheimer’s Disease, or those in poor medical health are not

eligible to enroll. Patients with Normal Pressure Hydrocephalus (NPH) or

those with other causes of dementia are not eligible to participate in the

study.

As with any surgery or procedure requiring general anesthesia, there are

risks involved. In this procedure, the risks are believed to be the same as

those for other surgical shunt placements. For example, risks may include

shunt infection, malfunction or failure, as well as risks associated with

general anesthesia.

This procedure is not for all Alzheimer’s patients as it is still

investigational. However, Alzheimer’s patients and their families,

caregivers, and treating physicians may participate in clinical studies that

evaluate new, investigational therapies by making informed decisions based

on their individual situation. Additional information about the study can be

found on the Eunoe, Inc. website (www.eunoe-inc.com). Interested parties

may also call 1.888.4MY.MIND (1.). (Participants will be

reimbursed for reasonable travel expenses)

Current research centers:

Pittsburgh, PA

Providence, RI

Portland, OR

Louisville, KY

Springfield, MA

Brooklyn, NY

Tucson AZ

San , TX

La Jolla, CA

sdale, AZ

Tampa, FL

Atlanta, GA

Ft. Myers, FL

Indianapolis, IN

St. Louis, MO

San Francisco, CA

Call 1-888-4MY-MIND or 1- or log on to http://www.eunoe-inc.com

to find out about participation.

[Guest guest]

http://www.ec-online.net/Knowledge/Newsletters/beacon101502.htm

Study of New Device-Based Treatment for Alzheimer’s Disease

An institute near you is investigating a device based treatment for

Alzheimer’s Disease.

Alzheimer’s Disease is the primary cause of senile dementia, affecting more

than 4.5 million US citizens. Advancing age is the key risk factor for

Alzheimer’s Disease. Unprecedented growth in the aging population will

increase the number of individuals afflicted with the disease for which

there is no known disease-modifying agent or cure. Once the disease

develops, the remaining life span of an Alzheimer’s sufferer is generally

reduced by a third. Progressive memory loss and changes in personality

occur early on. As the disease progresses, the patient becomes immobile and

dysfunctional, requiring increasing levels of care. Several drugs, such as

Aricept, Reminyl and Exelon, are currently marketed for the treatment of AD

symptoms. About one out of three patients respond and can tolerate the side

effects of these treatments. In such patients, these drugs can provide

symptomatic benefit, but generally only for 6 to 9 months.

Many avenues are being explored to find new treatments for this debilitating

disease. One approach, being pioneered by the biotechnology company Eunoe,

Inc, looks at helping the body restore its own healing properties. The

nervous system normally produces cerebrospinal fluid (CSF) that bathes the

brain, clears products of brain cell metabolism and provides the optimal

environment for brain cell function. In normal aging, CSF production

declines. In Alzheimer’s Disease patients, changes of normal aging may be

worsened by amyloid deposition in the cells that produce and clear CSF,

leading to marked CSF stagnation. The hypothesis is that impaired clearance

and/or diminished production of CSF leads to stagnation of CSF, resulting in

accumulation of toxic proteins and inflammatory mediators in the brain. Such

accumulated substances play a key role in ongoing brain injury in Alzheimer’

s Disease.

The COGNIShuntÒ System, a flow-controlled shunt being developed by Eunoe,

Inc., was designed to increase flow of CSF and improve clearance of

potential neurotoxins from the fluid bathing the brain without causing

overdrainage of CSF. The placement of this shunt provides a new way for CSF

to flow out of the brain’s fluid-filled cavities (ventricles) and into the

abdomen, where blood vessels absorb the fluid. Since the brain continuously

generates fresh, toxin-free CSF, the placement of this drainage system

should decrease the level of toxins in the fluid bathing the brain, while

allowing increased circulation of fresh, toxin-free, CSF. Decreasing the

toxins that may damage nerve cells in the brain may slow or stop the mental

decline associated with Alzheimer’s Disease.

Although this is a novel, investigative approach to treating Alzheimer’s

disease, the surgical procedure called shunting is a common procedure,

having been used successfully by neurosurgeons since the 1950’s to treat

other conditions such as hydrocephalus (excess fluid around the brain).

Every year, approximately 100,000 shunts are placed or revised in

hydrocephalus patients.

Data from a Eunoe, Inc. pilot feasibility study in 29 patients with mild to

moderate Alzheimer’s Disease, conducted under an FDA-granted Investigational

Device Exemption, indicate that the procedure and COGNIShunt System are well

tolerated in Alzheimer’s patients. The data from this feasibility study

also show a substantial difference in mental function over time, with better

preservation of mental ability in shunted patients versus the control group.

In addition, CSF levels of the potentially neurotoxic proteins found in

Alzheimer’s brain lesions, such as Tau and Amyloid, declined in shunted

patients and remained lower than their initial levels, even after twelve

months.

Based on the encouraging results of the feasibility study, Eunoe, Inc.

initiated a pivotal clinical trial that involves 25 sites throughout the

U.S. Those eligible to participate in the study must:

Have been diagnosed as having Alzheimer’ Disease

Be between 62 and 85 years old

Be a suitable candidate for surgical shunt implantation

Be able to read, speak, and understand English

Have a caregiver available to assist the subject in study participation and

to participate in some evaluations (questionnaires)

Otherwise be in good health

Patients with onset of Alzheimer’s Disease before age 60, family history of

early onset of Alzheimer’s Disease, or those in poor medical health are not

eligible to enroll. Patients with Normal Pressure Hydrocephalus (NPH) or

those with other causes of dementia are not eligible to participate in the

study.

As with any surgery or procedure requiring general anesthesia, there are

risks involved. In this procedure, the risks are believed to be the same as

those for other surgical shunt placements. For example, risks may include

shunt infection, malfunction or failure, as well as risks associated with

general anesthesia.

This procedure is not for all Alzheimer’s patients as it is still

investigational. However, Alzheimer’s patients and their families,

caregivers, and treating physicians may participate in clinical studies that

evaluate new, investigational therapies by making informed decisions based

on their individual situation. Additional information about the study can be

found on the Eunoe, Inc. website (www.eunoe-inc.com). Interested parties

may also call 1.888.4MY.MIND (1.). (Participants will be

reimbursed for reasonable travel expenses)

Current research centers:

Pittsburgh, PA

Providence, RI

Portland, OR

Louisville, KY

Springfield, MA

Brooklyn, NY

Tucson AZ

San , TX

La Jolla, CA

sdale, AZ

Tampa, FL

Atlanta, GA

Ft. Myers, FL

Indianapolis, IN

St. Louis, MO

San Francisco, CA

Call 1-888-4MY-MIND or 1- or log on to http://www.eunoe-inc.com

to find out about participation.