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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

Takeda Pharmaceutical Company Limited (“Takeda”) and its partner, Zinfandel Pharmaceuticals, Inc. (“Zinfandel”), recently 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.”

Source: Taleda Pharmaceutical Company Limited

Two Studies Advance Global Standardization of Biomarkers for Alzheimer’s Disease

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Alzheimer’s Consortium Identifies Five New Genes for Disease Risk

The Alzheimer’s Disease Genetics Consortium (ADGC) led by the University of Pennsylvania School of Medicine, the University of Miami, and the Boston University School of Medicine, recently identified five new genes linked to late-onset Alzheimer’s disease. The study, published in the journal Nature Genetics, describes data on ABCA7, MS4A6A/MS4A4E, CD2AP, CD33 and EPHA1, each of which contribute to the risk of dementia later in life.

Panel Calls for Biomarkers in Routine Clinical AD Diagnosis

Clinicians should try to incorporate biomarker data in their diagnosis of patients with Alzheimer’s disease or conditions potentially leading to it, an ad hoc expert panel recommended.

Levels of beta-amyloid or tau proteins in cerebrospinal fluid (CSF), or data from MRI or PET scans using amyloid-specific tracers, should be part of the differential diagnosis of Alzheimer-related disorders, according to two dozen members of the International Working Group for New Research Criteria for the Diagnosis of Alzheimer’s Disease.

Simple Blood Test May Detect Alzheimer’s: TTUHSC Researcher Featured in JAMA

The September issue of Archives of Neurology, one of the JAMA/Archives journals, features research, which finds that a simple blood test could diagnose Alzheimer’s disease.