Global Alzheimer’s Disease Phase 3 Clinical Trial Completes Enrollment

Takeda Pharmaceutical Company and partner Zinfandel Pharmaceuticals announced the completion of patient enrollment in the TOMMORROW Phase 3 Clinical Trial, one of the largest studies ever to be executed in mild cognitive impairment and Alzheimer’s disease (AD).

Previous research has shown that individuals who develop mild cognitive impairment (MCI) are at an increased risk of developing Alzheimer’s disease or another form of dementia, with yearly conversion rates of approximately 15 percent. So far, no medication studied has been shown to reliably delay the onset of Alzheimer’s.

The TOMMORROW trial is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in individuals between the ages of 65 and 83. The study enrolled approximately 3,500 people across 50 centers in the U.S., United Kingdom, Germany, Switzerland, and Australia, which have been randomized into the trial. According to a press release, the trial is set to last five years, or as much time as necessary to achieve 202 conversions to MCI due to Alzheimer’s in its high-risk group.

The TOMMORROW Phase 3 clinical trial is investigating a genetic-based Biomarker Risk Assignment Algorithm (BRAA), and evaluating the safety and efficacy of investigational drug pioglitazone 0.8 mg SR to postpone the onset of MCI due to Alzheimer’s in people with normal cognitive function projected to be at high risk.

The BRAA comprises three components: apolipoprotein E (APOE); Translocase of Outer Mitochondrial Membrane (TOMM40) genotypes; and age. An increase in age and some APOE genotypes has been shown to indicate an elevated risk of developing Alzheimer’s, according to prior research, but without sufficient sensitivity or specificity. The inclusion of the TOMM40 genotype could further refine risk determination, as hypothesized in this trial.

“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 Zinfandel CEO Allen Roses, M.D., in a previous press release. “This is why the TOMMORROW trial is important. The potential to identify an individual’s risk for developing MCI due to Alzheimer’s disease warrants further investigation.”