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Draft Research Plan

Cognitive Impairment in Older Adults: Screening

March 06, 2025

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

This document is available for Public Comments until Apr 02, 2025 11:59 PM EDT

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Figure 1 is the analytic framework that depicts the five Key Questions to be addressed in the systematic review. The figure illustrates how screening for cognitive impairment in adults age 65 years or older may result in improved intermediate outcomes (decision making) and health outcomes (patient, family/caregiver, and safety outcomes) (Key Question 1). There is also a question related to the accuracy of screening instruments used to detect cognitive impairment (Key Question 2) and potential harms of screening (Key Question 3). Additionally, the figure illustrates how interventions for cognitive impairment may have an impact on intermediate outcomes (decision making) and health outcomes (patient, family/caregiver, and safety outcomes) (Key Question 4) and whether these interventions result in any harms (Key Question 5).

Abbreviation: MCI=mild cognitive impairment

  1. Does screening for cognitive impairment in community-dwelling older adults improve decision making, patient, family/caregiver, or safety outcomes?
  2. What is the accuracy of screening instruments to detect cognitive impairment in community-dwelling older adults?
  3. What are the harms of screening for cognitive impairment in community-dwelling older adults? 
  4. Do interventions for cognitive impairment in community-dwelling older adults improve decision making, patient, family/caregiver, or safety outcomes?
  5. What are the harms of interventions for cognitive impairment in community-dwelling older adults? 

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. Does a diagnosis of cognitive impairment improve patient, family/caregiver, or clinician decision making?

For all Key Questions, we will describe the population and intervention characteristics of the included studies to assess the degree to which the evidence is representative of the U.S. population. Further, we will characterize the extent to which interventions are tailored to meet the needs of specific populations. We will also analyze the benefits and harms of interventions by populations to the extent that this is reported in the literature. Age may be an important characteristic as it may influence generalizability of treatment trials to screen-detected populations.

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the key questions.

  Included Excluded
Condition KQs 1–3: Any cognitive impairment (mild cognitive impairment or dementia)

KQs 4, 5: Mild cognitive impairment or mild to moderate dementia

 KQs 4, 5: Severe dementia
Populations KQs 1–3: Community-dwelling older adults (including those residing in independent and assisted living facilities) age ≥65 years without a current diagnosis of mild cognitive impairment or dementia

KQs 4, 5: Community-dwelling older adults (including those residing in independent and assisted living facilities) age ≥65 years with a current diagnosis of mild cognitive impairment or dementia; informal caregivers taking some responsibility for the care of the patient, such as a spouse, partner, relative, or friend
  • Studies comprised exclusively or predominantly of persons diagnosed with depression or psychosis, alcohol use disorder, HIV/AIDS, Down syndrome, posttraumatic brain injury, metabolic disorders, Parkinson’s disease, Huntington’s disease, or stroke
  • Persons living in special settings outside of the community (e.g., hospitals, skilled nursing facilities, rehabilitation facilities, subacute care facilities)
  • Professional caregivers who are formally or professionally trained and paid a salary
Settings Primary care outpatient settings (ambulatory care), home, and independent and assisted living facilities All KQs: Hospitals, skilled nursing facilities, rehabilitation facilities, subacute care facilities, emergency departments, or other settings not generalizable to primary care

KQs 1–3: Studies in which participants are recruited from memory, dementia, geropsychiatry, or neurology clinics
Screening Primary care–feasible screening instruments administered to the patient:
  • Very brief instruments (administered in <5 minutes) reported in two or more studies
  • Commonly used and studied brief instruments (administered in ≤10 minutes): Montreal Cognitive Assessment, Mini-Mental State Examination
 Biomarkers (cerebrospinal fluid, blood plasma, urine sampling) or imaging (computed tomography, magnetic resonance imaging, positron emission tomography)

Instruments not aimed at assessing cognitive function (e.g., IADLs), subjective report, or informant report
Interventions Patient pharmacologic interventions:

Pharmacologic interventions with a primary aim to reduce decline or improve patient cognitive function

  • Pharmacotherapy approved by the U.S. Food and Drug Administration (alone or in combination) for the treatment of mild and/or moderate dementia, included but not limited to:
    • Amyloid-targeted therapies (lecanemab, donanemab)
    • Acetylcholinesterase inhibitors (donepezil, galantamine, rivastigmine)
    • NMDA (N-methyl-D-aspartate) receptor antagonists (memantine)
  • Cessation of medications that may be contributing to cognitive impairment

Patient nonpharmacologic interventions:

  • Nonpharmacologic interventions aimed primarily at the patient:
    • Cognitive training, rehabilitation, or stimulation, with or without motor skills training interventions
    • Exercise interventions
    • Nutrition and lifestyle counseling interventions
    • Multidisciplinary and/or multicomponent care interventions involving assessment and care coordination
    • Education-only interventions

Caregiver interventions:

Nonpharmacologic interventions aimed primarily at the caregiver or caregiver-patient dyad
  • Interventions aimed at behavioral and psychological symptom management of dementia (such as behavioral treatments, antipsychotics, antiepileptics, and antidepressants for agitation, psychosis, depression, insomnia)
  • Cognitive impairment pharmacotherapies discontinued by the manufacturer (tacrine, aducanumab)
  • Medications used to treat cerebrovascular disease (e.g., antiplatelet medications, antihypertension medications, HMG-CoA reductase inhibitors)
  • Nonsteroidal anti-inflammatory drugs
  • Gonadal steroids
  • Vitamins, minerals, and antioxidants
  • Herbal supplements
  • Medical foods or fluids or nutrition therapy (e.g., meal replacement therapy)
  • Interventions aimed at primary prevention of cognitive impairment in those with baseline normal cognition
  • Respite care or day care interventions
Comparisons KQs 1, 3: No screening, usual care

KQ 2: Reference standard (clinical assessment or neuropsychologic testing with explicit diagnostic criteria)

KQs 3–5:

  • No intervention
  • Usual care
  • Wait list
  • Attention control
  • Minimal intervention
 KQs 4, 5: Active intervention
Outcomes KQs 1, 4:

Decision making outcomes:

  • Goal-concordant care: Healthcare, legal, and financial planning and decision making (e.g., advanced directives); safety planning; living arrangements

Patient-related outcomes:

  • Health-related quality of life
  • Incident dementia
  • Overall dementia severity
  • Cognitive function
  • Function: ADLs, IADLs, global function
  • Dementia-related symptoms/behaviors
  • Safety (falls, motor vehicle and other accidents, medication adherence/compliance/errors)
  • Unanticipated healthcare utilization (emergency use/hospitalizations)
  • Institutionalizations/nursing home admissions

Family/caregiver-related outcomes: (a priori defined as primary or secondary outcomes in the trial)

  • Health-related quality of life
  • Global stress/distress
  • Caregiver burden
  • Depression
  • Anxiety

Societal outcomes:

  • Safety outcomes

KQ 2: Sensitivity, specificity, or contingency table data allowing for calculation of sensitivity or specificity

KQ 3: Psychological harms (depression, anxiety, quality of life) and harms due to labeling (insurance status, driving privileges, independence)

KQ 5: Serious adverse events (e.g., death, serious adverse drug reactions), total adverse reactions from medications, withdrawals due to adverse events, and unexpected medical attention (e.g., emergency department visits, hospitalizations)		 KQs 1, 4:

Decision making outcomes: Cost-related outcomes

Patient-related outcomes: Cost-related outcomes; patient satisfaction (other than health-related quality of life); biomarker protein levels, brain matter volume, and brain cell activity level; function markers (e.g., Timed Up and Go Test, 6-meter timed walk, Functional Reach Test)

Family/caregiver-related outcomes: Cost-related outcomes; family/caregiver satisfaction (other than caregiver burden and health-related quality of life)

Societal outcomes: Cost-related outcomes

KQs 3, 5: Patient or family/caregiver dissatisfaction (other than psychological harms or patient adherence)
Timing of outcome assessment KQs 1, 4: ≥3 months after baseline

KQs 3, 5: No minimum followup

 KQs 1, 4: <3 months after baseline
Countries Studies conducted in countries categorized as “Very High” on the 2022 Human Development Index (as defined by the United Nations Development Programme) Studies conducted in countries that are not categorized as “Very High” on the 2022 Human Development Index
Study designs KQs 1: Randomized, controlled trials; nonrandomized controlled studies

KQ 2: Diagnostic accuracy studies

KQs 3: Randomized, controlled trials; nonrandomized controlled studies

KQ4: Randomized, controlled trials

KQ 5: Randomized, controlled trials included in KQ4; large observational studies for pharmacotherapies		 KQs 1, 4: Observational studies

KQ 2: Case-control studies

KQs 3, 5: Case series, case reports
Language English Languages other than English
Study quality Studies at low or moderate risk of bias Studies at high risk of bias (according to design-specific USPSTF criteria)

Abbreviations: ADLs=activities of daily living; IADLs=independent activities of daily living; KQ=key question; USPSTF=U.S. Preventive Services Task Force.