Navigation Links
Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer's Disease in Subjects Selected Using a Genetic-Based Biomarker Risk Assignment Algorithm

OSAKA, Japan and DURHAM, N.C., Aug. 26, 2013 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its partner, Zinfandel Pharmaceuticals, Inc. ("Zinfandel"), today announced the initiation of TOMMORROW, a global Phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm (risk assignment algorithm) to predict risk of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) within a five year period and to evaluate the efficacy of the investigational low dose pioglitazone (designated AD-4833 for this use) in delaying the onset of MCI due to AD in cognitively normal individuals at high risk as determined by the risk assignment algorithm.

The risk assignment algorithm is comprised of apolipoprotein E (APOE) and TOMM40 genotypes and age. Age and APOE genotype have previously been shown to indicate elevated risk of AD. The addition of TOMM40 is hypothesized to further refine the risk determination.

"To date, there have been a number of avenues investigated with the goal of altering the course of Alzheimer's disease but results have been unsuccessful," said Allen Roses, M.D., Chief Executive Officer, Zinfandel. "This is why the TOMMORROW trial is important. The potential to identify an individual's risk for developing MCI due to AD warrants further investigation."

AD is a devastating disease and diagnoses are increasing as the world's population ages. Currently 35.6 million people worldwide are living with some form of dementia. Studies show that individuals with MCI are at an increased risk of developing AD or another dementia with conversion rates of approximately 15 percent per year.

"AD-4833 is a member of a class of drugs known as PPAR (peroxisome proliferator-activated receptor)-gamma agonists which available data show may have a beneficial role in delaying symptoms of MCI due to AD," noted Stephen Brannan, M.D., Central Nervous System Development Therapeutic Area Head, Takeda. "TOMMORROW is a significant study and represents a novel clinical milestone and trial for the Alzheimer's community as it evaluates pre-symptomatic patients."

About the TOMMORROW Trial
The TOMMORROW trial is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. The trial will use a genetic–based biomarker risk assignment algorithm comprised of APOE and TOMM40 genotypes and age, which is being studied to determine the risk of individuals developing MCI due to AD within a five year period. Cognitively normal individuals assessed as low risk will be assigned to receive placebo. Cognitively normal individuals assessed as high risk will be assigned to AD-4833 or placebo. The study duration is approximately five years or the time needed to achieve 410 conversions to MCI due to AD in the high risk group. Approximately 5,800 cognitively normal individuals aged 65-83 at 50 centers worldwide will be randomized into the study. The study will recruit internationally from large, diverse, community-based populations.

The study has two objectives:

For the genetic-based biomarker risk assignment algorithm, the primary objective is to qualify the risk assignment algorithm for identification of subjects at high risk of developing MCI due to AD within the next five years. The primary endpoint for the risk assignment algorithm is time to diagnosis of MCI due to AD for placebo-treated, high-risk subjects versus placebo-treated, low-risk subjects.

For AD-4833, considered an investigational drug for this use, the primary objective is to evaluate the efficacy of AD-4833 versus placebo in delaying the onset of MCI due to AD in cognitively normal individuals assessed as high risk based on the risk assignment algorithm. The primary endpoint is time to diagnosis of MCI due to AD for AD-4833-treated subjects versus placebo-treated subjects in the high-risk stratum. Key secondary objectives are to evaluate the effect of AD-4833 versus placebo on the progression of cognitive decline and to compare the effects of AD-4833 versus placebo on functional decline and instrumental activities of daily living.

For more information on the TOMMORROW trial, please visit:

About Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD)
AD is a degenerative brain disease characterized by a progressive decline in memory, thinking, comprehension, calculation, language, learning capacity and judgment sufficient to impair personal activities of daily living. In 2011, the U.S. National Institute on Aging (NIA) and the Alzheimer's Association (AA) convened an expert panel to update the diagnostic guidelines for AD and also to develop criteria to define MCI due to AD and facilitate consensus in the field. Studies show that individuals with MCI are at an increased risk of developing AD or another dementia with conversion rates of approximately 15 percent per year. Approximately 18 million Americans are currently suffering from AD, and the rate of occurrence doubles every five years for those between 65 and 85 years of age. In the 2010 World Alzheimer Report, Alzheimer's Disease International estimated that there are 35.6 million people living with dementia worldwide in 2010, increasing to 65.7 million by 2030 and 115.4 million by 2050.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website,

About Zinfandel Pharmaceuticals
Zinfandel Pharmaceuticals, based in Durham, NC, is a privately held company dedicated to using pharmacogenetics to improve prediction of risk for Alzheimer's disease and thus facilitate the development of effective therapies.

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Takeda Launches New Subsidiary in Peru
2. Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohns Disease
3. Among New Agents Entering the Unipolar Depression Market Over the Next Decade, Lundbeck/Takeda Pharmaceuticals Brintellix Has Blockbuster Potential
4. Takeda Submits Biologics License Application for a New Investigational Drug Vedolizumab, in Moderately to Severely Active Crohns Disease and Ulcerative Colitis in the United States
5. Takeda Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone), Are Now Available in Pharmacies in the United States
6. AGA Research Foundation Announces Endowment Gift from Takeda Pharmaceuticals U.S.A., Inc. to Support Gastroenterology Research
7. Takeda to Acquire Inviragen, Inc.
8. Takeda Responds to Verdict in Diabetes Drug Case
9. Takeda Launches New Subsidiary in Ecuador
10. Takeda lanza nueva subsidiaria en Ecuador
11. Scripps Research Institute and Takeda Pharmaceuticals Announce Expanded Research Collaboration
Post Your Comments:
(Date:11/26/2015)... 26 november 2015 AAIPharma Services ... geplande investering aan van ten minste $15,8 ... en het mondiale hoofdkantoor in ... resulteren in extra kantoorruimte en extra capaciteit ... groeiende behoeften van de farmaceutische en biotechnologische ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and Markets ( ... Pacific Cardiac Pacemaker Market Outlook to 2019 - Rise in ... Demand " report to their offering. ... Boston scientific and others. ... including Medtronic, Biotronik, Boston scientific and ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the Global Cell Surface Testing ... Opportunities" report to their offering.  ... the addition of the  "2016 Future ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... ... Jobs in hospital medical laboratories and in the imaging field lead the many ... Medical Group . These fields, as well as travel nursing, ranked at ... through the company’s website, , The leading healthcare staffing agency released ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... Indosoft Inc., ... inclusion of an application server to improve system efficiency and reliability. , The new ... many of these standards, the system avoids locking itself into a specific piece of ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... recognized once again for its stellar workplace culture with the company’s Cincinnati office ... , Medical Solutions’ Cincinnati office was named a finalist in Cincinnati Business Courier’s ...
(Date:11/25/2015)... Friendswood, TX (PRWEB) , ... November 25, 2015 , ... ... through the companies’ “ Two Organizations, One Beat ” campaign. The partnership between the ... its services to aid in MAP International’s cause. , MAP International was founded in ...
(Date:11/25/2015)... Raton, Florida (PRWEB) , ... November 25, 2015 ... ... diagnostic testing for physicians and athletic programs, launches new Wimbledon Athletics ... importance of testing young athletes for unsuspected cardiac abnormalities. About 2,000 people under ...
Breaking Medicine News(10 mins):