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Cognitive Assessment Considerations: Understanding the Evidence

Research has shown that there are many possible causes of cognitive decline in older adults, including Alzheimer’s disease and related dementias. While some causes of cognitive decline are reversible, there is no cure for Alzheimer’s, nor are there current treatment options that are suitable for everyone living with this disease. However, early diagnosis can help individuals and their families plan for the future, live independently longer, participate in research, and find supports for daily living. Assessing for cognitive decline in doctor’s offices or other health care settings is a way for professionals to identify whether someone may be affected and determine if further assessments or tests are necessary.

Currently, cognitive testing practices and tools are not standardized, and have not been optimized for integration into clinical care, including primary care. This article outlines NIA’s research and steps others are taking to better understand when to test for cognitive impairment and what tools to use.

Who tests for cognitive impairment, when, and how?

Provider using a table to review cognitive assessment results of an older adult.

Although dementia is not a normal part of aging, it is more common as people age. Individuals and their family members are often the first to recognize that cognitive changes are occurring. They may seek evaluation from a primary care provider, who can collect information on the person’s family and medical history. A doctor should also initiate an assessment if they observe cognitive changes over the course of regular visits or as part of a physical exam. This assessment may involve a list of questions or tasks the patient is asked to perform in the office. Based on the results, the doctor may order additional tests and other diagnostics or refer the person to a specialist.

Many older adults (especially those who do not express memory concerns) are not tested for cognitive impairment. There are many possible reasons for this:

  • Testing people who are unlikely to have cognitive impairment can lead to false positives, which may cause unnecessary stress and worry among older adults and their families.
  • Physicians may be hesitant to take the time for cognitive testing or know what to do with a positive test, including how to tell the patient and their family.
  • Most cognitive testing tools have not been adequately assessed or adapted for use in neurodiverse populations, including people with intellectual and/or developmental disabilities. For example, adapted tools for assessing cognitive impairment are needed for people with Down syndrome, who are at an increased risk of developing Alzheimer’s.
  • Providers may not be sure of the best way to assess cognitive impairment or be familiar with the available tools.
  • Research shows that fewer than one-third of Medicare beneficiaries receive formal cognitive assessment at their annual wellness visit, even though it is covered as part of the visit. Possible explanations for this include stigma, fear, and discomfort about discussing a potentially sensitive topic.

Some people may also think there is no reason to identify cognitive decline early because there is no effective treatment or cure. However, promising new treatment approaches are emerging from research. In 2023, the Food and Drug Administration (FDA) approved a new drug that can slow Alzheimer’s in its early stages — the first such drug to receive full FDA approval. Other drugs to treat the disease are showing promise in early stages of clinical research.

In addition, studies of blood-based and other biomarkers for earlier detection of Alzheimer’s are advancing, which should aid doctors in personalizing treatment in cases where cognitive assessment indicates a possible problem. Once these approaches are more widely available, they could transform dementia screening, diagnosis, and management. Read more about how Alzheimer’s is diagnosed and treated.

The role of federal agencies in cognitive testing

Multiple federal agencies have been investing for many years in research to develop and test cognitive assessment approaches and to validate testing tools for use in clinical settings. Other federal agencies are invested in improving the utilization of tools. These efforts aim to improve testing for cognitive decline across populations, including older adults, neurodiverse individuals, and those with intellectual and/or developmental disabilities.

These federal agencies have roles in cognitive testing:

  • NIH. Several institutes within NIH play a role in federally funded research into cognitive assessment in diverse populations, developing new tools, evaluating the effectiveness of cognitive testing tools, and assessing the implementation of cognitive testing in research settings.
    • NIA is the lead federal agency for research on Alzheimer’s.
    • The National Institute of Neurological Disorders and Stroke (NINDS) is the lead federal agency for research on Alzheimer’s-related dementias.
    • The Eunice Kennedy Shriver Institute of Child Health and Human Development leads NIH research involving individuals with intellectual and/or developmental disabilities, including Down syndrome, who are at high risk for developing Alzheimer’s.
  • Agency for Healthcare Research and Quality (AHRQ). AHRQ produces evidence on health care to make it safer, higher quality, and more accessible, equitable, and affordable. AHRQ supports the U.S. Preventive Services Task Force (USPSTF), a volunteer panel of national experts that makes evidence-based recommendations about clinical preventive services, including cognitive screening. (See the following section for more details about the USPSTF’s work in this area.)
  • Centers for Disease Control and Prevention (CDC). CDC is the nation’s leading science-based, data-driven service organization that protects the public’s health. It is one of the major operating components of the U.S. Department of Health and Human Services (HHS). Through its National Healthy Brain Initiative, the CDC is promoting the development of professional competencies and addressing barriers to cognitive testing through state and local public health partnerships.
  • Centers for Medicare & Medicaid Services (CMS). CMS is the federal agency that provides health coverage for older adults and low-income Americans through the Medicare and Medicaid programs. CMS is responsible for reimbursing health care providers for services provided to program beneficiaries. For example, Medicare includes cognitive assessment as part of its coverage for annual wellness visits. (See the section “Cognitive assessment for Medicare beneficiaries,” below, for more details.)
  • FDA. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA’s coverage includes treatments and cognitive testing tools for dementia.
  • Indian Health Service (IHS). IHS is the agency within HHS responsible for providing federal health services to American Indians and Alaska Natives, who are at high risk of developing dementia but are often underdiagnosed. IHS provides funding to address diagnosis, assessment, management, and support for people with dementia within tribal communities.

These and other federal agencies are interested in identifying appropriate cognitive testing tools and ensuring that older Americans are appropriately assessed for cognitive impairment.

Systematic evidence reviews: The role of the U.S. Preventive Services Task Force

The USPSTF is an independent, volunteer panel of national experts that makes evidence-based recommendations about clinical preventive services, including cognitive screening. The USPSTF comprises 16 members, primarily clinicians who come from the fields of preventive medicine and primary care. The USPSTF, though not a governmental organization, is supported by AHRQ, which provides scientific, technical, administrative, and outreach support.

The USPSTF has periodically reviewed the scientific evidence for cognitive screening in the older adult population to determine if it should recommend cognitive screening for this group. Its process includes a systematic review of the evidence for potential benefits and harms of screening by evaluating the accuracy of available cognitive screening tests and the possible benefits of early detection on intervention and treatments. The USPSTF only recommends screening if the potential benefits exceed the potential harms, and if the benefits are demonstrated by scientific evidence.

In 2014 and 2020, the USPSTF conducted reviews that found the evidence insufficient to assess the balance of benefits and harms of screening for cognitive impairment in older adults. These recommendations only apply to USPSTF’s target demographic — community-dwelling older adults without cognitive impairment or concerns. The task force could not determine whether the benefits of screening outweighed the harms and found that clinical trials in the field had not clearly demonstrated the potential benefits of screening. The bottom line? More research is needed.

The USPSTF notes that in current practice, evaluation for or diagnosis of cognitive impairment most often occurs because of patient or family member concerns. Alternatively, a health care provider may observe changes in a person’s memory or thinking and determine that clinicians should remain alert to early signs or symptoms of cognitive impairment and evaluate the individual as appropriate.

NIH’s efforts to develop and validate cognitive assessment tools

After the USPSTF found insufficient evidence to recommend cognitive screening, NIA, NINDS, and others within NIH announced research opportunities to identify and validate short, easy-to-use cognitive assessment tools in clinical settings and evaluate the benefits of cognitive assessment on an individual’s quality of life and ability to prepare for the future. This research could help ensure that sufficient evidence is available for future USPSTF findings on cognitive screening.

DetectCID: Finding a tool that works in 10 minutes or less

To validate the effectiveness of a cognitive assessment tool, researchers must compare it with imaging and other diagnostic tools to demonstrate that it is accurate. It is also important that health care providers can use the tool within an average medical visit, which may last 15 minutes or less, and needs to include other tests and discussions. NIH is leading efforts to advance this research, including DetectCID, a national consortium established by NINDS to test and validate simple-to-use, standardized tools for assessing cognitive decline that take less than 10 minutes to administer. It can then provide turnkey clinical follow-up recommendations, based on the results, via a patient’s electronic medical record (EMR).

DetectCID research sites have developed three different clinical paradigms based on a range of approaches and tools. These include traditional pen-and-paper testing, assessment of the person’s gait, and sophisticated, user-friendly electronic platforms. NIH required the research teams to ensure that the tools can be used in different settings and with diverse populations. The DetectCID consortium is now working to optimize these tools, including providing follow-up recommendations via the EMR, by testing them in primary care and other everyday clinical settings. Preliminary data suggest that these are promising assessment approaches. Pragmatic clinical trials for integrating these paradigms in everyday care, including in populations that experience health disparities, started in 2022.

Finding tools that work for diverse populations

One important aspect of this research is ensuring that the tools work for diverse populations and in many different settings. Any widely used tools for assessing cognitive decline should be tested in underrepresented groups and be accessible to people in areas with limited resources.

The NIA-funded Multicultural Community Dementia Screening project is testing an online evaluation of cognitive impairment among 2,500 people from diverse backgrounds enrolled in a Florida health care plan. Then, the research team will recruit 500 research participants to contribute imaging and other diagnostic information to test the ability of the online evaluation to accurately predict cognitive impairment and dementia. Finally, the research team will explore the benefits versus the harms of screening via the online tool by assessing individuals’ advance care planning, quality of life, physical function, mental health, and other outcome measures after screening. The results of this research are expected in the next several years and will be designed to provide evidence of the potential benefits and harms of cognitive screening on patients and caregivers, as well as information on the effectiveness of the online assessment tool.

Multiple federal agencies, including NIH, are supporting the development of better dementia assessment tools and approaches for people with Down syndrome. For example, the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project is an NIH-wide initiative to better understand health conditions that affect individuals with Down syndrome, including Alzheimer’s and related dementias. Because it can be challenging to assess dementia in a population that already has a broad range of baseline intellectual disability, the INCLUDE Project aims to identify new measures of cognitive decline in adults with Down syndrome. Approaches under study include instruments adapted for this population, as well as biomarkers associated with the transition from normal aging to mild cognitive impairment to clinical dementia in people with Down syndrome. As part of this effort, the Alzheimer’s Biomarker Consortium-Down Syndrome (ABC-DS) Project is following a cohort of adults with Down syndrome over time to identify early biomarkers that may predict the onset of Alzheimer’s. The investigators hope that these biomarkers will be useful to inform future clinical trials and to improve the quality of life in people with Down syndrome.

Initiatives to monitor cognitive change digitally

Researchers are also exploring unobtrusive ways to detect cognitive impairment as people go about their daily lives. In June 2017, NIA released a notice of funding opportunity (NOFO) entitled Mobile Monitoring of Cognitive Change. This NOFO focused on the development and implementation of tools to monitor cognitive abilities and changes via mobile devices, including smartphones, in participants from racially, ethnically, and socioeconomically diverse backgrounds representing age groups ranging from 20 to 85. The results will then be extrapolated to nationally representative U.S. population samples. NIA granted two awards in response to this funding opportunity, and the research is underway.

If the mobile tools are found to be effective, researchers can look for ways to enhance access and expand their use. Researchers may also adapt the tools to collect research data about other aspects of a person’s daily life that could influence cognition, including environmental exposures and stress levels. Novel digital health technologies like these enable testing and validation in broader and more diverse populations, all without requiring in-person medical visits for people with cognitive impairment and their families. Federal agencies (including the FDA) have issued guidance on the use of software for drug development, software as a medical device, as well as other digital health technologies.

The Mobile Toolbox is another NIA-funded initiative focusing on digital cognitive assessments. The Mobile Toolbox offers smartphone-based cognitive tests that can be administered remotely to research participants. Clinical validation is in progress for six different studies involving participants who are at risk for mild cognitive impairment or Alzheimer’s, participants with cognitive impairment, participants with Parkinson’s disease, and people who are cognitively healthy. The research aims to expand the platform to include noncognitive measures and behavioral assessments and to allow studies to customize applications.

Using nontraditional methods to detect and track cognitive decline

Another area of research interest has focused on identifying standardized tools to assess aspects of daily life that may reflect early signs of cognitive impairment, such as the inability to identify scams or trouble managing money. For example, the NIA-funded Collaborative Aging (in Place) Research Using Technology (CART) initiative developed and validated a technology platform to assess the health and activity of older adults in the home, including indicators of possible cognitive impairment. The platform is a network of integrated digital devices that can monitor indicators of health and wellness under real-world conditions. During the initial testing, the CART platform was evaluated in a range of environments (e.g., rural and urban homes) and among geographically, racially, and ethnically diverse cohorts of participants. The platform was then made available to the wider research community, providing a way to track real-world physical, cognitive, and social activity patterns over time.

NIA is responding to the need for new approaches to cognitive assessment by sponsoring the PREPARE (Pioneering Research for Early Prediction of Alzheimer’s Disease & Related Dementias) Challenge. The goal of this competition is to spur innovative approaches that can ultimately lead to more accurate tests, tools, and methodologies for the early detection of dementia. The challenge emphasizes the importance of addressing health disparities by rewarding solutions that will benefit populations disproportionately impacted by Alzheimer’s and related dementias. Approaches will leverage advances in artificial intelligence, machine learning, and computing ecosystems to build and analyze open, sharable datasets. Over three phases, the challenge will advance algorithms and analytic approaches to enable state-of-the-art, ethical, and inclusive strategies for early detection.

  • Cognitive assessment for Medicare beneficiaries

    In 2011, the Affordable Care Act established the Annual Wellness Visit (AWV) for all Medicare beneficiaries. Similar to a routine physical exam, the AWV is designed as preventive health care to ensure patients have time to discuss nutrition, exercise, family and personal life, and lifestyle factors with their health care provider. As part of the AWV, the Affordable Care Act requires cognitive assessment for all Medicare beneficiaries age 65 and older.

    CMS, in consultation with NIH and AHRQ, and taking into consideration the USPSTF findings, does not require providers to use a specific tool or tools when assessing for cognitive impairment during the AWV, nor does it require the assessment to be conducted by a physician or nurse. However, CMS does direct providers to NIA information, which lists (but does not endorse) several available tools that providers may use to perform a cognitive assessment for Medicare beneficiaries. In practice, cognitive assessment at the AWV may include testing with one of the available tools or direct observation by the provider, while also considering subjective cognitive impairment concerns raised by the patient, family, friends, or caregivers.

A path forward: Testing for cognitive decline in older adults

While the issue of cognitive assessments is complex, the federal government is working to advance research so that it may provide clear evidence for the USPSTF and others indicating:

  • When cognitive assessment by primary health care providers is appropriate for asymptomatic adults
  • Which tool or tools are recommended in these situations

In addition, NIH and other agencies are working to eliminate disparities by ensuring that effective tools for testing cognitive decline are identified and validated for use in all older adult populations, including individuals with intellectual and developmental disabilities. Through programs like the INCLUDE Project, researchers are building the evidence needed to develop sensitive diagnostic tools for diverse groups, which will help ensure that cognitive abnormalities can be detected accurately and effectively in everyone.

As a research agency, NIH cannot recommend or endorse specific cognitive testing tools for use in a particular setting. NIH’s role is to fund research to inform AHRQ and CMS recommendations. NIA does provide information to guide health care professionals and to help support them in deciding when cognitive assessment is appropriate and identify available tools. NIA also provides information for individuals and their families both before a diagnosis (for example, what to ask, expect from, and bring to an appointment) and after a diagnosis (for example, next steps for planning).

The USPSTF will conduct another systematic review of the evidence on cognitive screening for older adults without subjective concerns around memory and thinking in 2026. By that point, research efforts supported by NIH and other agencies will provide additional evidence for understanding the benefits and risks of cognitive assessment with validated tools for a wide range of older adult populations.

This content is provided by the NIH National Institute on Aging (NIA). NIA scientists and other experts review this content to ensure it is accurate and up to date.

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