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LY450139, A Phase III Clincal Trial on the Progression of Alzheimer’s Disease

This clinical trial is worth considering. Patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. This means every participant gets the drug. Additionally, all patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.This means you can continue receiving the drug free of charge after participation in the clinical trial.

LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer’s patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease.


Primary Outcome Measures: Alzheimer’s Disease Assessment Scale – Cognition (ADAS-Cog). Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

Secondary Outcome Measures:

All of these test will be conducted throughout the study.

* The Clinical Dementia Rating Scale (CDR)

* Neuropsychiatric Inventory (NPI)

* Resource Utilisation in Dementia – Lite Questionnaire

* Quality of Life in Alzheimer’s Disease (Qol-AD)

* Mini-mental State Examination (MMSE)

* A chemical marker of AD in the blood which may be lowered by LY450139.

* Energy usage (metabolism) seen on a brain scan called FDG-PET

* Brain size (volume) seen with AD on a brain scan called vMRI

* Amount of brain amyloid plaque using a brain scan called AV-45-PET

* A chemical marker (tau) known to be elevated in the spinal fluid in AD

* To measure levels of LY450139 and their effect on safety, chemical markers and effectiveness.

This is a very thorough clinical trial.

To get the specifics of the clinical trial including: purpose, eligibility, inclusion criteria and available locations go to Effects of LY450139, on the Progression of Alzheimer’s Disease as Compared With Placebo (IDENTITY-2)

Here is some additional information from the Eli Lilly website.

Eli Lilly and Company (NYSE: LLY) has announced today the start of a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer’s disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer’s disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer’s patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer’s disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

The IDENTITY Trial – Interrupting Alzheimer’s Dementia by EvaluatiNg Treatment of AmyloId PaThologY

IDENTITY is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a “randomized delayed start” design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.

“Alzheimer’s is a devastating disease that destroys brain cells, affecting everything from a patient’s memory to their work and social life. Currently available medications treat the symptoms of Alzheimer’s disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the IDENTITY clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate,” said Eric Siemers M.D., Medical Director, Alzheimer’s disease research for Eli Lilly and Company.

Alzheimer’s disease is a progressive neurodegenerative condition that is the most common cause of dementia in patients over 65 years of age. Estimates show that 6-8% of people over age 65 are affected by Alzheimer’s disease(1), totaling approximately 5 million people in the United States alone(2). Every 72 seconds, an American is developing Alzheimer’s disease(3), and it is the seventh-leading cause of death in the United States(4). The direct and indirect health care costs associated with Alzheimer’s disease in the U.S. are estimated to be about $150 billion(5). In 2005, the total cost worldwide was estimated at $315.4 billion(6).

Given the aging population, without the availability of medicines that delay or prevent the onset of Alzheimer’s disease, the number of affected people is expected to at least triple by the year 2050 in developed nations(7). The average duration between onset of symptoms and death due to complications of Alzheimer’s disease is about 8-10 years(8). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimer’s disease, when patients cannot maintain independent function and are frequently bedridden.

To more completely characterize the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer’s disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer’s disease pathology is possible.

Additional information regarding the IDENTITY trial, including global recruitment sites, may be found by visiting www.clinicaltrials.gov or www.lillytrials.com, or by calling 1-877-CTLilly (1-877-285-4559).

About LY450139

LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer’s disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhea, upset stomach, and fatigue. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.

Original content the Alzheimer’s Reading Room

 

Clinical Trial: Effect of LY450139 on the Long Term Progression of Alzheimer’s Disease

This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain.


Purpose

Alzheimer’s disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase inhibits the production of A-Beta amyloid as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial, patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient’s participation will last approximately two years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.

Eligibility
Ages Eligible for Study: 55 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

* Meets criteria for mild to moderate AD with Mini-Mental State Examination score of 16 through 26 at visit 1
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT)scan in the last 2 years with no findings inconsistent with a diagnosis of Alzheimer’s disease
* If female must be without menstruation for at least 12 consecutive months or have had both ovaries removed.

Exclusion Criteria:

* Is not capable of swallowing whole oral medication
* Has serious or unstable illnesses
* Does not have a reliable caregiver
* Chronic alcohol or drug abuse within the past 5 years
* Has ever had active vaccination for AD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594568

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations and More Information

 

Clinical Trial: Effect of LY450139 on the Long Term Progression of Alzheimer’s Disease

This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain.


Purpose

Alzheimer’s disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase inhibits the production of A-Beta amyloid as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both A-Beta amyloid and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial, patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient’s participation will last approximately two years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.

Eligibility
Ages Eligible for Study: 55 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

* Meets criteria for mild to moderate AD with Mini-Mental State Examination score of 16 through 26 at visit 1
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT)scan in the last 2 years with no findings inconsistent with a diagnosis of Alzheimer’s disease
* If female must be without menstruation for at least 12 consecutive months or have had both ovaries removed.

Exclusion Criteria:

* Is not capable of swallowing whole oral medication
* Has serious or unstable illnesses
* Does not have a reliable caregiver
* Chronic alcohol or drug abuse within the past 5 years
* Has ever had active vaccination for AD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594568

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations and More Information

 

Lilly Launches Its First Phase III Trial for Treatment of Alzheimer’s Disease

clipped from www.prnewswire.com

Late-stage IDENTITY study of once-daily, oral agent is now enrolling
patients

Eli Lilly and Company
(NYSE: LLY) has announced today the start of a Phase III clinical trial
studying LY450139, an investigational gamma secretase inhibitor for the
treatment of mild to moderate Alzheimer’s disease.

Slowing the rate of disease progression could preserve independent
functioning and quality of life for Alzheimer’s patients in the milder
stages of the disease, potentially delaying the onset of the severe stages
of the disease.

LY450139 is being tested
to see if it can slow the progression associated with Alzheimer’s disease
by inhibiting gamma-secretase, an enzyme that can create a sticky protein
called amyloid beta.

IDENTITY is a randomized, double-blind, placebo-controlled trial that
will be conducted in the U.S. and 21 additional countries.

information regarding the IDENTITY trial, including global
recruitment sites, may be found at clinicaltrials.gov

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