Takeda and Zinfandel Pharmaceuticals to Present Data at Upcoming Alzheimer's Association International Conference® Highlighting Innovative Approaches to Alzheimer's Disease Research and Development

OSAKA, Japan and DURHAM, N.C., July 10, 2014 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and its partner, Zinfandel Pharmaceuticals, Inc. ("Zinfandel"), will present data during multiple poster and oral sessions at the upcoming Alzheimer's Association International Conference^® 2014 (AAIC^®), taking place in Copenhagen, Denmark from July 12-17, 2014.

"Studies show that individuals with mild cognitive impairment—a slight, although noticeable and measurable decline in cognitive abilities—are at an increased risk of developing Alzheimer's disease or another dementia. An option to be able to predict an individual's risk for developing this disease would be welcomed by the medical community," said Stephen Brannan, M.D., Central Nervous System Development Therapeutic Area Head, Takeda. "Therefore, a special focus for Takeda at this conference will be presenting updates on the TOMMORROW Trial—a trial that challenges the status quo and aims to accelerate the progress toward identifying effective therapeutic agents for Alzheimer's disease."

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 apolipoprotein E (APOE) and Translocase of Outer Mitochondrial Membrane (TOMM40) genotypes and age, which is being studied to determine the risk of individuals developing mild cognitive impairment (MCI) due to Alzheimer's disease (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 low dose pioglitazone (AD-4833 0.8 SR mg QD) 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 60 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 genetic-based biomarker risk algorithm to determine the risk of developing MCI due to AD within a five year period. The primary endpoint for the genetic-based biomarker risk algorithm is time to diagnosis of MCI due to AD for placebo-treated, high-risk subjects versus placebo-treated, low-risk subjects; and to evaluate the efficacy of the investigational agent, low dose pioglitazone (AD-4833 0.8 SR mg QD) in delaying the onset of MCI due to AD in cognitively normal individuals (aged 65-83) as determined by the genetic-based biomarker risk algorithm. The primary endpoint is time to diagnosis of MCI due to AD for pioglitazone (AD-4833 0.8 SR mg QD) treated subjects versus placebo-treated subjects in the high-risk stratum.

Key secondary objectives are to evaluate the effect of low dose pioglitazone (AD-4833 0.8 SR mg QD) versus placebo on the progression of cognitive decline and to compare the effects of low dose pioglitazone (AD-4833 0.8 SR mg QD) versus placebo on functional decline and instrumental activities of daily living.

For more information on the TOMMORROW trial, please visit: www.clinicaltrials.gov.

About 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. 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 people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com. 

About Zinfandel Pharmaceuticals
Zinfandel Pharmaceuticals, based in Durham, N.C., 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