NIH Unveils Alzheimer's Prevention Trial

BETHESDA, Md. -- Federal officials released an Alzheimer's prevention plan Tuesday and announced two large-scale clinical trials, including the first-ever prevention trial for the progressive brain disease.

The trials, which were announced by National Institutes of Health (NIH) Director Francis Collins, MD, at an Alzheimer's conference here, are both in late stages and early results could be announced later this year. They are part of the government's push to prevent or find a treatment for Alzheimer's disease by 2025. A draft of the plan was first released in February.

Collins and Health and Human Services (HHS) Secretary Kathleen Sebelius called the investment in the two clinical trials "historic" and "bold." Collins said he hoped the trials would spur additional research that would some day yield important answers about Alzheimer's disease.

"Here we are poised to get this momentum going," Collins said.

One of the trials being funded by the NIH is 5-year prevention trial focusing on an extended family of about 5,000 people living in Colombia, members of which have a genetic mutation that predisposes them to exhibit signs of Alzheimer's beginning at the age of 45, sometimes before.

The trial will test whether Genentech's investigational Alzheimer's drug crenezumab can delay the onset of Alzheimer's when given to the Colombian family members before they show signs of the disease. Crenezumab, a humanized monoclonal antibody, binds to amyloid plaque in the brain, which is present in large amounts in the brains of people with Alzheimer's disease and is being explored as a proposed contributor to the disease.

Results from several Alzheimer's trials testing other anti-amyloid agents have been disappointing, but the new trial will be the first testing an anti-amyloid agent in patients who don't yet have Alzheimer's.

The NIH is funding a portion of the trial with a $16 million grant. The nonprofit Phoenix-based Banner Health, which is running the study, and Genentech will cover the remaining costs of the study.

A second study, which is funded with a $7.9 million grant from NIH, will test whether a nasal spray that delivers insulin to the brain can improve memory function among 240 patients in the trial who have mild cognitive impairment and early Alzheimer's disease.

Funding for the national plan comes from the $500 million the Obama administration allocated for Alzheimer's for fiscal 2012.

President Obama's proposed fiscal 2013 budget also would provide $100 million to boost efforts to combat Alzheimer's disease. The bulk of that money -- $80 million -- is slated to go toward clinical research, and rest will go toward public awareness campaigns, provider education programs, caregiver support, and a improved data collection.

The national Alzheimer's plan includes $2 million in funding for training for doctors, nurses, and other healthcare providers on recognizing symptoms of and managing Alzheimer's disease.

HHS also debuted a new TV ad, and announced a new website, www.alzheimers.gov, to offer resources and support to patients and caregivers.

The Alzheimer's Association applauded the plan.

"This is a strong plan that promises important progress when implemented," Harry Johns, president and CEO of the Alzheimer's Association, said in a statement. "For all Americans – not just the more than 5 million living with Alzheimer's and their 15 million caregivers today – this plan is an historic achievement."