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Effective Health Care Program

Treatment of Clinical Alzheimer’s-type Dementia (CATD) and the Diagnosis of CATD and Mild Cognitive Impairment (MCI)

Key Questions

Draft Key Questions

KQ 1a: What is the comparative effectiveness and harms of pharmacologic and nonpharmacologic interventions for slowing cognitive decline in adults with clinical Alzheimer's-type dementia (CATD)?

KQ 1b: Do the harms or effectiveness differ as a function of patient characteristics (i.e., age, sex, race/ethnicity, family history, education, socioeconomic status, risk factor status)?

KQ 2: What is the comparative effectiveness and harms of pharmacologic and nonpharmacologic interventions for preventing and responding to agitation/aggression and other behavioral disturbances in adults with CATD:

  1. Among community-dwelling adults?
  2. In nursing home and assisted living settings?

KQ 3: In adult patients with suspected mild cognitive impairment (MCI) or clinical Alzheimer's-type dementia (CATD), what are the comparative accuracy of the combinations of tests* used to diagnose MCI or CATD and the potential harms of undergoing the tests?

*CATD is not diagnosed using a single test.

Figure 1. Draft analytic framework for Key Question 1

 

 This figure depicts key question 1 within the context of the PICOTS described in the previous section. In general, the figure illustrates pharmacologic and non-pharmacologic interventions aimed at improving cognition or slowing decline, improving quality of life and activities of daily living or slowing decline in adults with Clinical Alzheimer's-type Dementia (CATD) may result in intermediate outcomes such as changes in biomarker protein level(s), brain matter volume, and brain cell activity level;  and/or long-term outcomes such as cognitive improvement, cognitive stability, cognitive decline as determined by validated cognitive test results and quality of life, as determined by SF-36.

Figure 2. Draft analytic framework for Key Question 2

 This figure depicts key question 2 within the context of the PICOTS described in the previous section. In general, the figure illustrates pharmacologic and non-pharmacologic interventions aimed at preventing and responding to behavioral disturbances in adults with CATD may result in intermediate outcomes such as staff behavior change or reduction in antipsychotic use and/or final outcomes such as frequency, duration, and severity of aggressive behaviors; general behavior of people with dementia; distress; quality of life; and injuries to residents, staff, and others; and/or secondary outcomes such as staff distress, burden, quality of life.

Figure 3. Draft analytic framework for Key Question 3

 This figure depicts key question 3 within the context of the PICOTS described in the previous section. In general, the figure illustrates tests aimed at diagnosing Mild Cognitive Impairment (MCI) or CATD in adults with suspected MCI or CATD may result in differing levels of accuracy.

Background

Dementia is severely disabling, impacting quality of life and abilities, potentially to the point of institutionalization. The burden is not only on the patient, but also on the family and other caregivers. Moreover, the financial burden is high. RAND estimated that, in 2010, the per-patient cost was $41,689-$56,290 per year; the total US cost was estimated at $109 billion for care, and $159-$215 billion if the value included informal care1. The prevalence of dementia ranges from 5 to 7%2. There are a variety of pharmacologic and nonpharmacologic treatments for individuals with Clinical Alzheimer's Type Dementia (CATD) aimed at maintaining cognition and quality of life and controlling behavioral disturbances; however, there is no agreement on which intervention(s) are most effective and have the fewest harms, when to initiate treatment, and when to end treatment. 

Population(s)

  • KQ 1 and 2: Adults with CATD 
  • KQ 1b: subgroups of adults with CATD by age, sex, race/ethnicity, family history, education, socioeconomic status, risk factor status
  • KQ 3: Adults with suspected CATD and MCI

Interventions

  • KQ 1:
    • FDA- approved pharmacologic interventions aimed at improving cognition or slowing decline, improving QoL and ADL or slowing decline (e.g. donepezil, galantamine, memantine, rivastigmine)
    • Nonpharmacologic interventions aimed at improving cognition or slowing decline, improving QoL and ADL or slowing decline (including respite care and day care interventions)
  • KQ 2:
    • Pharmacologic interventions to prevent and respond to behavioral disturbances (e.g. antipsychotics, sedative hypnotics)
    • Nonpharmacologic interventions to prevent and respond to behavioral disturbances (such as herbal supplements such as ginko biloba, music, light, pet, reminiscence, or psychodynamic interpersonal therapy; nighttime home monitoring systems; Snoezelen® multisensory environments)
  • KQ 3:
    • Single or in combination:
      • Blood/Cerebrospinal Fluid (CSF) tests
      • Validated cognitive tests
      • Brain scans
        • Structural imaging – Computerized tomography (CT), Magnetic Resonance Imaging (MRI); Positron Emission Tomography (PET)
        • Functional imaging – PET, Function MRI (fMRI)
        • Molecular imaging – PET, fMRI, Single-photon Emission Computed Tomography (SPECT)
      • Other diagnostic tests

Comparators

  • KQ 1 and 2:
    • Usual care (as specified by trial investigators)
    • Attention control or placebo
    • Other nonpharmacologic interventions
  • KQ 3:
    • Other diagnostic tests

Outcomes

KQ 1:

  • Final health or patient-centered outcomes:
    • Cognitive improvement, cognitive stability, cognitive decline as determined by validated cognitive test results
    • Activities of Daily Living (ADL) and Quality of Life (QoL) (e.g. as determined by SF-36 and others)
  • Intermediate outcomes:
    • Such as results of imaging tests and biomarkers
  • Adverse effects of intervention(s):
    • Adverse effects of interventions (such as increased symptoms including depression, anxiety and wandering)

KQ 2:

  • Final health or patient-centered outcomes:
    • Frequency, duration, and severity of aggressive behaviors
    • general behavior of people with dementia
    • distress
    • quality of life
    • injuries to residents, staff, others
  • Secondary Outcomes
    • Staff distress
    • burden
    • quality of life
  • Intermediate Outcomes
    • Staff behavior change
    • Reduction in antipsychotic use
  • Adverse Effects of Intervention(s)
    • Adverse effects of interventions (such as increased symptoms including depression, anxiety and wandering)

KQ 3:

  • Final Outcomes
    • Sensitivity
    • Specificity
    • Positive predictive value
    • Negative predictive value
  • Adverse Effects of Test(s)
    • Adverse effects of tests (harms)
    • False positives
    • False negatives
    • Cost (e.g. missed work)

Timing

  • All

Setting

  • KQ 1:
    • Community-dwelling (people with dementia living at home)
    • Assisted living
  • KQ 2:
    • Nursing home and Assisted living
    • Community-dwelling
  • KQ 3:
    • Community-dwelling (people with suspected MCI or dementia, living at home)
    • Assisted living

References

  1. Hurd , M.D., et al., Monetary Costs of Dementia in the United States. New England Journal of Medicine, 2013. 368(14): p. 1326-1334. http://www.nejm.org/doi/10.1056/NEJMsa1204629
  2. Sosa-Ortiz AL, A.-C.I., Prince MJ, Epidemiology of dementias and Alzheimer's disease. Arch Med Res, 2012. 43. https://www.ncbi.nlm.nih.gov/pubmed/?term=Sosa-Ortiz+AL%2C+A.-C.I.%2C+Prince+MJ%2C+Epidemiology+of+dementias+and+Alzheimer's+disease