Largest Alzheimer's Disease Study Seeking Recruitment Help from FPs

The Alzheimer's Disease Neuroimaging Initiative (ADNI) is asking for help from family physicians throughout the United States.

The largest and most comprehensive Alzheimer's disease research effort in history, ADNI is moving into its second phase -- ADNI2 -- but finds itself hampered by recruitment challenges.

According to principal investigator Michael Weiner, M.D., a professor of medicine, radiology, psychiatry and neurology at the University of California, San Francisco, ADNI2 is seeking 400 volunteers between the ages of 55 and 90 who have been diagnosed with early mild cognitive impairment, late mild cognitive impairment or early/mild Alzheimer's disease.

Participants also must

A five-year longitudinal study, ADNI was named in the National Plan to Address Alzheimer's Disease (page 15 of 69-page PDF; About PDFs) that was unveiled by HHS in mid-May. The plan sets forth five goals, including the development of effective prevention and treatment approaches for Alzheimer's disease and related dementias by 2025.

To support this goal, the president's proposed fiscal year 2013 budget includes an $80 million increase to fund additional Alzheimer's research, as well as an additional $20 million for related programs.

Weiner said ADNI is working to predict and monitor the onset and progression of Alzheimer's disease using biomarkers found in blood and cerebrospinal fluid, as well as MRI scans and various positron emission tomography imaging methods.

"There have been lots of advances … and some of these measurements are looking at the basic biology of what's going on in the brain as the disease progresses," Weiner told AAFP News Now. "Biomarkers allow us to better detect who does and does not have the disease and allow us to characterize the subjects.

"We also use the biomarkers to measure progression, and if a treatment is effective in slowing progress, we ought to be able to pick that up."

Weiner said that the main goal of the study -- the validation of biomarkers for use in future clinical trials that focus on detection, as well as those that focus on treatment -- is what he calls "the ADNI method."

"The method is already being used, and that will increase as more and more drugs get tested, but the extension of this is that (drugs tested via the ADNI method) are going to begin to find their way into the clinical marketplace, and (ADNI-validated biomarkers can be incorporated) into standard diagnostic techniques that family physicians will be interested in using," he said. "The lessons learned from the ADNI project are going to have an influence on how physicians decide how they're going to use these tests."

ADNI currently is operating in 55 clinical sites across the United States and Canada. Sponsored by the NIH, the study is funded through the NIH Foundation and the Canadian Health Research Institute.

The NIH is providing a patient handout (1-page PDF; About PDFs) and a brochure (2-page PDF) to physicians interested in referring patients to ADNI2.

Weiner said he would appreciate any referrals FPs can send the study's way and wants to allay fears doctors may have about sending patients elsewhere.

"The sites will do the research, but I want to be clear that the sites aren't going to steal patients away from referring physicians," he said. "We want family physicians to continue following their patients, but we also need those patients to participate in the research.

"It would be a huge help to the whole field that's trying to find effective treatments for Alzheimer's disease."