New IDEAS study begins enrollment for patients with cognitive impairment, dementia
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The Alzheimer’s Association announced the start of recruitment for the New IDEAS: Imaging Dementia — Evidence for Amyloid Scanning study, which aims to determine if amyloid PET scans improve diagnosis and treatment of Alzheimer’s disease.
The FDA approved brain amyloid PET scans for identifying amyloid accumulation, a “hallmark” brain change related to AD, according to a press release on the news from the Alzheimer’s Association. The scans are indicated for patients with mild cognitive impairment or dementia of an undetermined cause.
The New IDEAS study is open to Medicare beneficiaries who meet clinical criteria for mild cognitive impairment or dementia according to the 2018 National Institute on Aging – Alzheimer’s Association Research Framework. These beneficiaries are eligible for inclusion in the study through a referral from a participating dementia specialist.
The release from the Alzheimer’s Association noted that more than half of the planned participants in the New IDEAS study — at least 4,000 of 7,000 participants — will be “Black/African American and Hispanic/Latino.” These populations are “historically underrepresented in dementia research,” according to the release.
“The New IDEAS study aims to be among the most racially and ethnically diverse [AD] studies ever launched,” Gil Rabinovici, MD, Edward Fein and Pearl Landrith Distinguished Professor in Memory & Aging at University of California, San Francisco, and principal investigator of the study, said in the release.
Currently, there is limited information about the impact of amyloid PET scans in diverse populations with mild cognitive impairment and dementia, according to Maria C. Carrillo, PhD, chief science officer for the Alzheimer’s Association.
“As treatment options advance in the pipeline, and the number of people with [AD] and other dementia continue to grow, we need to significantly advance our understanding of early detection and diagnosis, especially in underserved populations,” she said in the release.
Participants in the New IDEAS study will be enrolled during the course of 30 to 36 months across 350 sites in the United States, according to the release. Upon enrollment, participants may receive a brain amyloid PET scan; Medicare will reimburse patients for scans depending on coverage plans. Patients will be responsible for annual deductibles and copays (up to 20%). Coverage for patients with Medicare Advantage plans will vary.
The New IDEAS study will serve as a follow-up to the original IDEAS study, which included more than 18,000 participants and provided “the strongest phase 4 data to date” to support the role of brain amyloid PET scans in the management of patients with cognitive impairment, with regard to medications, referrals for counseling and diagnosis of the cause of the cognitive impairment.