Study explores possible future for early Alzheimer's diagnostics

The REAL AD study is the first of its kind in terms of focus and scope. Principal investigators are the University of Gothenburg and the Västra Götaland Region, VGR, which represents a model region for Swedish healthcare. All hundred-plus care centers within VGR Närhälsan, one of the largest primary care providers in Sweden, are included in the study, together with some additional sampling sites.

REAL AD addresses all people aged 50-80 who do not have a diagnosis of dementia and who can go to a care center within VGR Närhälsan. Anyone who meets the criteria can participate regardless of which health center they are listed at.

Tests of memory and thinking ability at home

Starting point is a digital study portal, available in Swedish, English, Finnish and Arabic, where participants receive all information about the study and clear instructions about the next steps. First, cognition, i.e. memory and thinking ability, is tested at home using digital tools for three months. Participants are then invited to provide a blood sample at any of the 111 sampling points around VGR. Participants can complete the digital cognition tests in three additional rounds, after 18, 27 and 36 months, and provide a second blood sample after 18 months. The tests are relatively quick and can be done in all four languages.

The study is led by Michael Schöll, professor at Gothenburg University and research group leader in close collaboration with the co-investigators and a team of project leaders.

- REAL AD is a seriously ambitious project, and it has been an enormous challenge to democratize the study design. It must reflect both urban and rural areas, be accessible to as many participants as possible and involve the entire VGR Närhälsan, which means that even the most remote healthcare centers must be able to participate in terms of sample handling and transport, he says.

Signs of Alzheimer's in a simple blood test

Central hub of the study is a laboratory environment in neurochemistry, located at the Sahlgrenska Academy at the University of Gothenburg and the Sahlgrenska University Hospital Mölndal, with professors Kaj Blennow and Henrik Zetterberg at the helm. The researchers will study so-called Alzheimer's biomarkers in the participants' blood samples, which have been shown to be early signs of the disease.

In addition, a separate study will then be conducted enrolling a smaller number of randomly selected participants who are also thoroughly examined clinically at Sahlgrenska University Hospital to confirm the results of the digital cognition tests and blood analyses. The clinical part of the study is carried out at the university hospital memory clinic in collaboration with professor and senior physician Silke Kern.

Knowledge base for healthcare and research

The research focuses on the potential for early diagnosis based on digital cognitive tests and blood markers. If the combination of the tools works to detect early signs of disease in the general population, the hope is that they will be used in primary care in the future to follow individuals over time and identify Alzheimer's with greater certainty and much earlier than is often the case today.

"The need for earlier diagnosis is widely accepted, also in view of the new treatments that are around the corner. Many if not most diagnoses are made in primary care in Sweden, so diagnostics must be strengthened there, and knowledge is needed about whether it will be feasible to screen for Alzheimer's in the general population. In the short term, society does not have the resources to establish a lot of new specialized memory clinics," says Michael Schöll.

"The study is important, and the timing is perfect. We are closer than ever before to a treatment option for Alzheimer's, but we are not sufficiently prepared," he says.

The study needs at least 3,000 participants but has capacity to enroll up to 10,000 volunteers. It is accompanied by information via Närhälsan and several other marketing efforts.

Research ethics do not allow researchers to share individual information with participants since experimental tools are used. Individuals do thus not receive a cognitive rating or diagnosis, and their participation is unpaid.

"What we are offering is participation in a community where we will actively inform about progresses in Alzheimer's research, also via information meetings, which we know many people are asking for. By participating in the study, you also help our healthcare to prepare for an enormous challenge," concludes Michael Schöll.