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Category Archives: clinical trial

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

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Baxter initiates phase III study to evaluate Gammagard Liquid for Alzheimer’s disease

This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for GAMMAGARD LIQUID as a potential treatment for Alzheimer’s disease.

This clinical trial is active but not yet actively recruiting participants. This is the official name of the clinical trial, Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in PID Subjects . You can learn more about the trial including eligibility requirements and locations by following the link. We will alert you when they start actively recruiting patients.

More information GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

Baxter Initiates GAMMAGARD LIQUID Phase III Trial for the Treatment of Alzheimer’s Disease

Baxter Healthcare Corporation today announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration (FDA) review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous (IGIV)], marketed as KIOVIG in European Union, for the treatment of mild-to-moderate Alzheimer’s disease. This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for GAMMAGARD LIQUID as a potential treatment for the disease.

The Phase III trial is a prospective, 18-month, randomized, double-blind, placebo-controlled, two dose-arm, parallel study in 360 subjects of both genders, ages 50 to 89 years old, with dementia of mild-to-moderate severity. The study will determine whether GAMMAGARD LIQUID treatment results in a significantly slower rate of decline of cognitive and other functions compared to placebo. Approximately 40 U.S. leading academic centers have been identified and will begin clinical trial enrollment within the next several weeks.

Efficacy will be assessed by two primary endpoints:

* Cognitive outcomes using the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and
* Global clinical outcome as assessed by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC).

Secondary endpoints to be assessed at 18 months include behavioral, functional and quality of life outcome measures. Other secondary endpoints will include several plasma, cerebrospinal fluid, and imaging biomarkers to assess disease progression and response to therapy.

The trial is sponsored by Baxter and partially funded by the National Institutes of Health (NIH) through the Alzheimer’s Disease Cooperative Study (ADCS). The ADCS is a cooperative agreement between the National Institute of Aging and the University of California San Diego (UCSD). The ADCS was developed in response to a perceived need to advance research in the development of therapies that might be useful for treating patients with Alzheimer’s disease. The trial will be managed by Paul Aisen, M.D., director of the Alzheimer’s Disease Cooperative Study and professor, department of Neurosciences, UCSD. The involvement of the ADCS and NIH in the conduct of the Phase III trial should help ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD LIQUID in the treatment of Alzheimer’s disease.

The project leader for the trial is Norman Relkin, M.D., PhD, director of the Memory Disorders Program and behavioral neurologist and neuroscientist at New York-Presbyterian/Weill Cornell Medical Center, and associate professor of clinical neurology at Weill Cornell Medical College in New York City. Dr. Relkin is also the lead investigator for the Phase I and II studies with GAMMAGARD LIQUID for the same indication.

GAMMAGARD LIQUID contains a broad spectrum of immunoglobulins (antibodies). The therapy is approved for use as an immunoglobulin replacement therapy that boosts the immune system in patients with primary immunodeficiency disorders. The precise mechanisms of the therapy’s effects in Alzheimer’s disease are not yet known.

Original content at the Alzheimer’s Reading Room.

 

GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

Results of 9-Month Phase II Study

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.


NewYork-Presbyterian/Weill Cornell Announces Results of 9-Month Phase II Study of GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

NewYork-Presbyterian Hospital/Weill Cornell Medical Center announced today the nine-month interim results of an ongoing Phase II clinical trial of GAMMAGARD Intravenous Immunoglobulin (IGIV) for Alzheimer’s disease at the Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) in Chicago.

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

Just last April, at the American Academy of Neurology (AAN) meeting in Chicago, the six-month outcomes of the double-blind, placebo-controlled Phase II trial were presented. Now, interim data from the extension of that study show persistence of benefits for Alzheimer’s patients treated continuously over 9 months. This is the first study to show persistence of benefits for Alzheimer’s from IGIV with continuous treatment for 9 months. Previous studies discontinued therapy after 6 months.

The lead researcher for the trial is Dr. Norman Relkin, a behavioral neurologist and neuroscientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Dr. Relkin is director of the Memory Disorders Program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Clinical Neurology at Weill Cornell Medical College in New York City.

Working in collaboration with Dr. Relkin is Dr. Diamanto Tsakanikas, the neuropsychologist for the Phase II study. Dr. Tsakanikas is Clinical Assistant Attending Neuropsychologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and an Instructor of Neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College.

Baxter International Inc. supported the study and provided GAMMAGARD Liquid and GAMMAGARD S/D for the trial. GAMMAGARD contains a broad spectrum of immunoglobulins (antibodies), and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency disorders.

In the double-blind, placebo-controlled Phase II study, 24 patients in the United States with mild to moderate Alzheimer’s disease were randomly assigned to receive GAMMAGARD LIQUID (eight patients), GAMMAGARD S/D (eight patients) or saline placebo (eight patients). In the open-label extension of this study, all patients were treated for a total of 18 months. The study included a comparison of four dosing regimens of GAMMAGARD, with doses ranging from 0.2 g/kg every two weeks to 0.8 g/kg every month.

Cognitive, behavioral and functional measures were collected at baseline and every three months thereafter. The primary endpoints of the Phase II trial were cognitive function, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and global function, as assessed by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (CGIC). Safety and tolerability of IGIV treatment in Alzheimer’s patients were also assessed relative to placebo. Secondary endpoints included effects on biomarkers related to beta amyloid, a peptide related to Alzheimer’s disease.

In today’s presentation at ICAD, Dr. Relkin reported that subjects who received uninterrupted IGIV therapy for 9 months demonstrated significantly better cognitive and overall clinical outcomes compared to initially placebo-treated subjects. Dr. Relkin also reported that uninterrupted treatment with IGIV resulted in further improvements in activities of daily living.

Statistically significant differences favoring IGIV treatment were observed on the CGIC at 3, 6 and 9 months. After nine months, the group of patients treated with GAMMAGARD averaged 1.4 points higher than initially placebo-treated patients on the CGIC, a commonly used measure of overall outcome in Alzheimer’s clinical trials. At six months, the same group of patients had averaged 1.2 points higher than placebo-treated patients on the CGIC.

On the ADAS-Cog, a test of cognition, change scores numerically favored the IGIV-treatment at 3, 6 and 9 months, with the difference reaching statistical significance at 3 and 9 months. The average change in ADAS-Cog score at nine months of treatment favored treatment with GAMMAGARD by 5.4 ADAS points. The average change in ADAS-Cog score at six months of treatment had favored GAMMAGARD by 2.6 ADAS points. In an analysis by dose arm, subjects receiving 0.4g IGIV/kg/2 weeks improved over baseline on ADAS-Cog scores in 4 of 4 cases at 9 months. None of the subjects given placebo initially showed comparable improvements.

The scientists also measured activities of daily living (ADL) — the actual performance of each subject in common daily activities, as reported by caregivers. ADL is broken down into three increasing levels of severity: 1) independence, 2) supervision/required verbal reminders or instruction, and 3) physical assistance for daily tasks — including eating, toileting, bathing, grooming, dressing, reading, travel and using common household appliances. The research team found that experimental subjects either slightly improved or slightly declined over the study period. However, subjects in the placebo group showed a greater drop in ADL score.

The IGIV group showed minimal decline in carrying out daily tasks and performed better than initially placebo–treated patients on measures of activities of daily living. On average, there was a 7-point difference (-9.6 ADL point score in the placebo group compared to -2.5 ADL point score in the experimental group) between the IGIV (at all doses administered) and the placebo group. There was an 11-point difference between the 9-month performance of the IGIV group (+2 ADL points) and that of the placebo group (-9 ADL points). “Effects on daily function of this magnitude can make a difference in the lives of Alzheimer’s patients and their caregivers,” Dr. Tsakanikas commented.

Last year, in August 2007, NewYork-Presbyterian/Weill Cornell announced preliminary results of the Phase II study, indicating that the study provided further encouragement for carrying out a Phase III trial.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

The Phase II study follows Dr. Relkin’s earlier Phase I results in eight patients that were recently published in the journal Neurobiology of Aging (Feb. 2008). Although the findings of the Phase I and II trials are encouraging, both studies were small and must be evaluated in larger, sufficiently powered studies.

The Phase III trial will be sponsored jointly by the National Institutes of Health (NIH) and Baxter Healthcare, and additional studies may be required. The study protocol was submitted to the U.S. Food and Drug Administration for review, with the intention of initiating patient recruitment later this year. The trial will include about 35 leading academic centers in the United States that are members of The Alzheimer’s Disease Cooperative Study (ADCS). The involvement of the ADCS and NIH in the conduct of the Phase III trial will ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD in the treatment of Alzheimer’s patients.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org and http://www.med.cornell.edu.

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GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

Results of 9-Month Phase II Study

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.


NewYork-Presbyterian/Weill Cornell Announces Results of 9-Month Phase II Study of GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

NewYork-Presbyterian Hospital/Weill Cornell Medical Center announced today the nine-month interim results of an ongoing Phase II clinical trial of GAMMAGARD Intravenous Immunoglobulin (IGIV) for Alzheimer’s disease at the Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) in Chicago.

The nine-month results show significantly better global outcomes, cognitive performance and daily functioning in patients treated with IGIV compared to initially placebo-treated patients.

Just last April, at the American Academy of Neurology (AAN) meeting in Chicago, the six-month outcomes of the double-blind, placebo-controlled Phase II trial were presented. Now, interim data from the extension of that study show persistence of benefits for Alzheimer’s patients treated continuously over 9 months. This is the first study to show persistence of benefits for Alzheimer’s from IGIV with continuous treatment for 9 months. Previous studies discontinued therapy after 6 months.

The lead researcher for the trial is Dr. Norman Relkin, a behavioral neurologist and neuroscientist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. Dr. Relkin is director of the Memory Disorders Program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and Associate Professor of Clinical Neurology at Weill Cornell Medical College in New York City.

Working in collaboration with Dr. Relkin is Dr. Diamanto Tsakanikas, the neuropsychologist for the Phase II study. Dr. Tsakanikas is Clinical Assistant Attending Neuropsychologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and an Instructor of Neuropsychology in the Department of Neurology & Neuroscience at Weill Cornell Medical College.

Baxter International Inc. supported the study and provided GAMMAGARD Liquid and GAMMAGARD S/D for the trial. GAMMAGARD contains a broad spectrum of immunoglobulins (antibodies), and is indicated as an immunoglobulin replacement therapy in patients with primary immunodeficiency disorders.

In the double-blind, placebo-controlled Phase II study, 24 patients in the United States with mild to moderate Alzheimer’s disease were randomly assigned to receive GAMMAGARD LIQUID (eight patients), GAMMAGARD S/D (eight patients) or saline placebo (eight patients). In the open-label extension of this study, all patients were treated for a total of 18 months. The study included a comparison of four dosing regimens of GAMMAGARD, with doses ranging from 0.2 g/kg every two weeks to 0.8 g/kg every month.

Cognitive, behavioral and functional measures were collected at baseline and every three months thereafter. The primary endpoints of the Phase II trial were cognitive function, as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and global function, as assessed by the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (CGIC). Safety and tolerability of IGIV treatment in Alzheimer’s patients were also assessed relative to placebo. Secondary endpoints included effects on biomarkers related to beta amyloid, a peptide related to Alzheimer’s disease.

In today’s presentation at ICAD, Dr. Relkin reported that subjects who received uninterrupted IGIV therapy for 9 months demonstrated significantly better cognitive and overall clinical outcomes compared to initially placebo-treated subjects. Dr. Relkin also reported that uninterrupted treatment with IGIV resulted in further improvements in activities of daily living.

Statistically significant differences favoring IGIV treatment were observed on the CGIC at 3, 6 and 9 months. After nine months, the group of patients treated with GAMMAGARD averaged 1.4 points higher than initially placebo-treated patients on the CGIC, a commonly used measure of overall outcome in Alzheimer’s clinical trials. At six months, the same group of patients had averaged 1.2 points higher than placebo-treated patients on the CGIC.

On the ADAS-Cog, a test of cognition, change scores numerically favored the IGIV-treatment at 3, 6 and 9 months, with the difference reaching statistical significance at 3 and 9 months. The average change in ADAS-Cog score at nine months of treatment favored treatment with GAMMAGARD by 5.4 ADAS points. The average change in ADAS-Cog score at six months of treatment had favored GAMMAGARD by 2.6 ADAS points. In an analysis by dose arm, subjects receiving 0.4g IGIV/kg/2 weeks improved over baseline on ADAS-Cog scores in 4 of 4 cases at 9 months. None of the subjects given placebo initially showed comparable improvements.

The scientists also measured activities of daily living (ADL) — the actual performance of each subject in common daily activities, as reported by caregivers. ADL is broken down into three increasing levels of severity: 1) independence, 2) supervision/required verbal reminders or instruction, and 3) physical assistance for daily tasks — including eating, toileting, bathing, grooming, dressing, reading, travel and using common household appliances. The research team found that experimental subjects either slightly improved or slightly declined over the study period. However, subjects in the placebo group showed a greater drop in ADL score.

The IGIV group showed minimal decline in carrying out daily tasks and performed better than initially placebo–treated patients on measures of activities of daily living. On average, there was a 7-point difference (-9.6 ADL point score in the placebo group compared to -2.5 ADL point score in the experimental group) between the IGIV (at all doses administered) and the placebo group. There was an 11-point difference between the 9-month performance of the IGIV group (+2 ADL points) and that of the placebo group (-9 ADL points). “Effects on daily function of this magnitude can make a difference in the lives of Alzheimer’s patients and their caregivers,” Dr. Tsakanikas commented.

Last year, in August 2007, NewYork-Presbyterian/Weill Cornell announced preliminary results of the Phase II study, indicating that the study provided further encouragement for carrying out a Phase III trial.

The latest results of the Phase II trial re-affirm the decision, initially announced in August 2007, to move to a Phase III study evaluating the role of Gammagard LIQUID for the treatment of patients with mild to moderate Alzheimer’s disease with a nine-month primary outcome endpoint. The decision to move to Phase III was based on the results of two completed open-label clinical studies and the preliminary six-month interim analysis of the Phase II trial.

The Phase II study follows Dr. Relkin’s earlier Phase I results in eight patients that were recently published in the journal Neurobiology of Aging (Feb. 2008). Although the findings of the Phase I and II trials are encouraging, both studies were small and must be evaluated in larger, sufficiently powered studies.

The Phase III trial will be sponsored jointly by the National Institutes of Health (NIH) and Baxter Healthcare, and additional studies may be required. The study protocol was submitted to the U.S. Food and Drug Administration for review, with the intention of initiating patient recruitment later this year. The trial will include about 35 leading academic centers in the United States that are members of The Alzheimer’s Disease Cooperative Study (ADCS). The involvement of the ADCS and NIH in the conduct of the Phase III trial will ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD in the treatment of Alzheimer’s patients.

This study was supported by Baxter Healthcare, the Citigroup Foundation and The Clinical Translational Science Center (CTSC) of Weill Cornell Medical College.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances — from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial for gene therapy for Parkinson’s disease, the first indication of bone marrow’s critical role in tumor growth, and, most recently, the world’s first successful use of deep brain stimulation to treat a minimally-conscious brain-injured patient. NewYork-Presbyterian, which is ranked sixth on the U.S.News & World Report list of top hospitals, also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children’s Hospital of NewYork-Presbyterian, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian Hospital/The Allen Pavilion. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree oversees and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org and http://www.med.cornell.edu.

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Bapineuzumab in Patients With Mild to Moderate Alzheimer’s Disease

This is a Phase III clinical trial and the study is currently recruiting participants.

This is a multi center, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient’s participation will last approximately 1.5 years.


You can get all the specifics on this Phase III clinical trial at Clinical Trials.gov.

For a quick look at the locations participating in the study go to Locations

You can visit the Elan website to learn more about Bapineuzumab

 

Efficacy and safety of tarenflurbil in mild to moderate Alzheimer’s disease: a randomised phase II trial

We will try to keep you posted when the Phase 3 trial begins. Feel free to subscribe to our email list if you would like to be notified.

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800 mg tarenflurbil twice per day was well tolerated for up to 24 months of treatment, with evidence of a dose-related effect on measures of daily activities and global function in patients with mild AD.


Source, Findings

A prespecified interaction analysis revealed that patients with mild AD (baseline MMSE 20–26) and moderate AD (baseline MMSE 15–19) responded differently to tarenflurbil in the ADAS-cog and the ADCS-ADL (p≥0·10); therefore, these groups were analysed separately. Patients with mild AD in the 800 mg tarenflurbil group had lower rates of decline than did those in the placebo group in activities of daily living (ADCS-ADL difference in slope 3·98 [95% CI 0·33 to 7·62] points per year, effect size [reduction from placebo decline rate] 46·4%, Cohen’s d 0·45; p=0·033) and global function (CDR-sb difference −0·80 [−1·57 to −0·03] points per year, effect size 35·7%, Cohen’s d 0·42; p=0·042); slowing of cognitive decline did not differ significantly (ADAS-cog difference −1·36 [−4·07 to 1·36] points per year, effect size 33·7%, Cohen’s d 0·20; p=0·327). In patients with moderate AD, 800 mg tarenflurbil twice per day had no significant effects on ADCS-ADL and ADAS-cog and had a negative effect on CDR-sb (−52%, Cohen’s d −1·08; p=0·003). The most common adverse events were diarrhoea (in seven, nine, and five patients in the 800 mg, 400 mg, and placebo groups, respectively), nausea (in seven, seven, and four patients), and dizziness (in five, nine, and four patients). Patients with mild AD who were in the 800 mg tarenflurbil group for 24 months had lower rates of decline for all three primary outcomes than did patients who were in the placebo group for months 0–12 and a tarenflurbil group for months 12–24

Interpretation

800 mg tarenflurbil twice per day was well tolerated for up to 24 months of treatment, with evidence of a dose-related effect on measures of daily activities and global function in patients with mild AD.

Funding
Myriad Pharmaceuticals.

 

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

 
 
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