Phase 3 of Large-scale Alzheimer’s Disease Study Looking to Enroll Hundreds of Participants

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is searching for participants to enroll in one of the largest and longest trials on Alzheimer’s disease.

This ongoing study aims to develop biomarkers for the early detection and tracking of Alzheimer’s over time.

Researchers need to enroll approximately 800 participants, between 55 and 90 years old, across 60 sites in the United States and Canada. The study is looking healthy volunteers without memory problems, people with mild memory impairments, and patients diagnosed with mild dementia due to Alzheimer’s disease. There is no medication involved.

“One of the biggest challenges researchers face is finding people to volunteer to take part in studies,” Michael Weiner, MD, principal investigator of the study, said in a press release. “We can beat Alzheimer’s, but we can’t do it without volunteers. We need help.”

ADNI, funded by the National Institutes of Health, was launched in 2004, and has helped validate biomarkers for the disease, including blood tests, cerebrospinal fluid tests, and imaging with magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.

Now in its third phase, ADNI3 (NCT02854033) intends to determine the relationships between the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the entire spectrum of Alzheimer’s disease, which evolves from normal aging through very mild symptoms, to mild cognitive impairment and later, dementia.

ADNI3 continues the previously funded ADNI-1, ADNI-GO (NCT01078636), and ADNI-2 (NCT01231971) studies, in which academic and industry partners collaborated to determine the relationships between the clinical, cognitive, imaging, genetic, and biochemical biomarker characteristics of the entire spectrum of Alzheimer’s disease.

Researchers will track cognitive function through computer tests at home and in a doctor’s office, including assessing the changes in an individual’s ability to handle money — a common warning sign of the disease.

Researchers will also monitor the levels of tau and amyloid proteins — both markers of Alzheimer’s disease — in the brain, using state-of-the-art imaging techniques and will collect cerebral spinal fluid (CSF) for up to five years.

Approximately 1,070-2,000 participants will be enrolled at 59 sites in the United States and Canada, of whom 700-800 will be rollover participants from previous ADNI studies, and 370-1,200 will be newly enrolled.

A better understanding of how Alzheimer’s progresses is crucial to develop strategies to not only treat but also prevent the disease. To do this, researchers need the vital help of volunteers who are at the heart of all stages of the ADNI study.

“It is extremely important that more people get involved in the fight against Alzheimer’s disease, which affects nearly all of us in some way,” Weiner said. “We need to know how Alzheimer’s disease progresses in order to discover new treatments that could significantly improve the way we treat it in the future.”

Interested volunteers can find more information on recruitment and trial details on the official ADNI3 website here.