[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Pages 64837-64843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27361]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Diagnostic and
Treatment of Clinical Alzheimer's-Type Dementia (CATD)
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review of Diagnostic and
Treatment of Clinical Alzheimer's-type Dementia (CATD), which is
currently being conducted by the AHRQ's Evidence-based Practice Centers
(EPC) Program. Access to published and unpublished pertinent scientific
information will improve the quality of this review.
DATES: Submission Deadline on or before January 17, 2019.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
[[Page 64838]]
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Diagnostic and
Treatment of Clinical Alzheimer's-type Dementia (CATD). AHRQ is
conducting this systematic review pursuant to Section 902(a) of the
Public Health Service Act, 42 U.S.C. 299a(a).
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Diagnostic and Treatment of Clinical Alzheimer's-type
Dementia (CATD), including those that describe adverse events. The
entire research protocol, including the key questions, is also
available online at: https://effectivehealthcare.ahrq.gov/topics/alzheimers-type-dementia/protocol.
This is to notify the public that the EPC Program would find the
following information on Diagnostic and Treatment of Clinical
Alzheimer's-type Dementia (CATD) helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, please provide a summary, including the
following elements: study number, study period, design, methodology,
indication and diagnosis, proper use instructions, inclusion and
exclusion criteria, primary and secondary outcomes, baseline
characteristics, number of patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety
results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered,
the protocol for the study including a study number, the study
period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization
for this indication and an index outlining the relevant information
in each submitted file.
Your contribution will be very beneficial to the EPC Program.
Materials submitted must be publicly available or able to be made
public. Materials that are considered confidential; marketing
materials; study types not included in the review; or information on
indications not included in the review cannot be used by the EPC
Program. This is a voluntary request for information, and all costs for
complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
The Key Questions
KQ 1: In adults with CATD, what are the efficacy and harms of
prescription pharmacological interventions versus placebo/inactive
control for treatment of cognition, function, and quality of life?
KQ 1a: In adults with CATD, does the efficacy of prescription
pharmacological interventions versus placebo/inactive control vary
as a function of patient characteristics (i.e., age, sex, race/
ethnicity, depression, pre-treatment cognitive or functional level/
CATD stage, living setting)?
KQ 2: In adults with CATD, what are the efficacy and harms of
nonprescription pharmacological interventions versus placebo/
inactive control for treatment of cognition, function, and quality
of life?
KQ 2a: In adults with CATD, does the efficacy of nonprescription
pharmacological interventions versus placebo/inactive control vary
as a function of patient characteristics (i.e., age, sex, race/
ethnicity, depression, pre-treatment cognitive or functional level/
CATD stage, living setting)?
KQ 3: In adults with CATD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus other active interventions for treatment of
cognition, function, and quality of life?
KQ 3a: In adults with CATD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus other prescription pharmacological
interventions for treatment of cognition, function, and quality of
life?
KQ 3b: In adults with CATD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus nonprescription pharmacological interventions
for treatment of cognition, function, and quality of life?
KQ 3c: In adults with CATD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus nonpharmacological interventions for treatment
of cognition, function, and quality of life?
KQ 3d: In adults with CATD, does the comparative effectiveness
of prescription pharmacological interventions versus other active
interventions for treatment of cognition, function, and quality of
life vary as a function of patient characteristics (i.e., age, sex,
race/ethnicity, depression, pre-treatment cognitive or functional
level/CATD stage, living setting)?
KQ 4: In adults with CATD and behavioral and psychological
symptoms of dementia (BPSD), what are the efficacy and harms of
prescription pharmacological interventions versus placebo/inactive
control for treatment of BPSD?
KQ 4a: In adults with CATD and BPSD, what are the efficacy and
harms of prescription pharmacological interventions versus placebo/
inactive control for reducing frequency and severity of future BPSD?
KQ 4b: In adults with CATD and BPSD, does the efficacy of
prescription pharmacological interventions versus placebo/inactive
control for reducing frequency and severity of future BPSD vary as a
function of patient characteristics (i.e., age, sex, race/ethnicity,
depression, pre-treatment cognitive or functional level/CATD stage,
pre-treatment BPSD severity, living setting)?
KQ 4c: In adults with CATD and BPSD, what are the efficacy and
harms of prescription pharmacological interventions versus placebo/
inactive control for acute treatment of BPSD?
KQ 4d: In adults with CATD and BPSD, does the efficacy of
prescription pharmacological interventions versus placebo/inactive
control for acute treatment of BPSD vary as a function of patient
characteristics (i.e., age, sex, race/ethnicity, depression, pre-
treatment cognitive or functional level/CATD stage, pre-treatment
BPSD severity, living setting)?
KQ 5: In adults with CATD and BPSD, what are the efficacy and
harms of nonprescription pharmacological interventions versus
placebo/inactive control for treatment of BPSD in adults with CATD
and BPSD?
KQ 5a: In adults with CATD and BPSD, what are the efficacy and
harms of nonprescription pharmacological interventions versus
placebo/inactive control for reducing frequency and severity of
future BPSD?
KQ 5b: In adults with CATD and BPSD, does the efficacy of
nonprescription pharmacological interventions versus placebo/
inactive control for reducing frequency and severity of future BPSD
vary as a function of patient characteristics (i.e., age, sex, race/
ethnicity, depression, pre-treatment cognitive or functional level/
CATD stage, pre-treatment BPSD severity, living setting)?
KQ 5c: In adults with CATD and BPSD, what are the efficacy and
harms of
[[Page 64839]]
nonprescription pharmacological interventions versus placebo/
inactive control for acute treatment of BPSD?
KQ 5d: In adults with CATD and BPSD, does the efficacy of
nonprescription pharmacological interventions versus placebo/
inactive control for acute treatment of BPSD vary as a function of
patient characteristics (i.e., age, sex, race/ethnicity, depression,
pre-treatment cognitive or functional level/CATD stage, pre-
treatment BPSD severity, living setting)?
KQ 6: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus other active interventions for treatment of
BPSD?
KQ 6a: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus other prescription pharmacological
interventions for reducing frequency and severity of future BPSD?
KQ 6b: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus nonprescription pharmacological interventions
for reducing frequency and severity of future BPSD?
KQ 6c: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus nonpharmacological interventions for reducing
frequency and severity of future BPSD?
KQ 6d: In adults with CATD and BPSD, does the comparative
effectiveness of prescription pharmacological interventions versus
other active interventions for reducing frequency and severity of
future BPSD vary as a function of patient characteristics (i.e.,
age, sex, race/ethnicity, depression, pre-treatment cognitive or
functional level/CATD stage, pre-treatment BPSD severity, living
setting)?
KQ 6e: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus other prescription pharmacological
interventions for acute treatment of BPSD?
KQ 6f: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus nonprescription pharmacological interventions
for acute treatment of BPSD?
KQ 6g: In adults with CATD and BPSD, what are the comparative
effectiveness and harms of prescription pharmacological
interventions versus nonpharmacological interventions for acute
treatment of BPSD?
KQ 6h: In adults with CATD and BPSD, does the comparative
effectiveness of prescription pharmacological interventions versus
other active interventions for acute treatment of BPSD vary as a
function of patient characteristics (i.e., age, sex, race/ethnicity,
depression, pre-treatment cognitive or functional level/CATD stage,
pre-treatment BPSD severity, living setting)?
KQ 7: In adults with suspected CATD, what are the accuracy,
comparative accuracy, and harms of different individual cognitive
diagnostic tests and their combinations for making the diagnosis of
CATD as defined by full clinical evaluation and/or
neuropsychological testing with explicit diagnostic criteria?
KQ 7a: Do the accuracy and comparative accuracy of cognitive
tests for making the diagnosis of CATD as defined by full clinical
evaluation and/or neuropsychological testing with explicit
diagnostic criteria vary as a function of patient characteristics
(i.e., age, sex, race/ethnicity, education, pre-testing cognitive or
functional level CATD stage)?
KQ 8: In adults with a clinical diagnosis of CATD, what are the
accuracy, comparative accuracy, and harms of brain imaging, CSF, and
blood tests for diagnosing pathologically confirmed Alzheimer's
disease as the underlying etiology?
KQ 8a: Do the accuracy and comparative accuracy of brain
imaging, CSF, and blood tests for pathologically confirmed
Alzheimer's disease as the underlying etiology of CATD vary as a
function of patient characteristics (i.e., age, sex, race/ethnicity,
depression, education, pre-testing cognitive or functional level
CATD stage)?
[[Page 64840]]
Table 1--PICOTS
[Populations, interventions, comparators, outcomes, timing, settings/study design]
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Treatment
comparator or
KQ Population Intervention diagnostic Health outcomes Timing Setting Study design
reference & harms
standard
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KQ 1-3: Drug treatment Adults with CATD Prescription For efficacy Efficacy and >=24 weeks..... Cognitive Efficacy and
efficacy, comparative >=50 years of pharmacologic comparisons: comparative outcomes: comparative
effectiveness & harms on age. (drug) Placebo, Other effectiveness: Community- effectiveness:
cognition, function & Patient treatment: inactive Change in dwelling, RCT, CCT,
quality of life. characteristics Cholinesterase control. patient Assisted systematic
to be assessed inhibitors, For comparative cognition living. review of RCTs
as possible NMDA effectiveness (global screen, Functional & or CCTs.
treatment antagonists. comparisons: multidomain, QOL outcomes: Harms: RCT,
effect Nonprescription Prescription memory, Community- CCT,
modifiers: Age, pharmacologic drug treatment, executive dwelling, controlled
Sex, Race/ (drug) Nonprescription function, Assisted prospective
ethnicity, treatment: OTC drug treatment, language, living, cohort studies
Depression, Pre- supplements, Nondrug attention), Nursing home. with >=1,000
treatment Vitamins, treatment. function, or participants,
cognitive or Herbals. QOL on systematic
functional validated test. review of any
level/CATD Change in of these study
stage, Living disease stage designs.
setting. based on
validated test.
Change in
patient ``at
home'' IADL or
ADL function.
Change in
patient
residence to
different level
of independence.
Harms:
General: FDA
defined SAEs,
Withdrawals due
to AEs.
Psychiatric:
Somnolence,
Confusion/
Delirium.
Nonpsychiatric:
Falls,
Extrapyramidal
symptoms,
Stroke.
Mortality (all-
cause, CVD, non-
CVD).
KQ 4-6: Drug treatment Adults with CATD Prescription Efficacy Efficacy and Agitation, Community- Efficacy and
efficacy, comparative >=50 years of pharmacologic comparisons: comparative aggression, dwelling, comparative
effectiveness & harms on age with BPSD treatment: Placebo, Other effectiveness: psychosis or Assisted effectiveness:
BPSD. (studies Cholinesterase inactive Primary: Change Disinhibited living, RCT, CCT,
specified BPSD inhibitors, control. in the sexual Nursing home. systematic
inclusion NMDA Comparative frequency and/ behavior review of RCTs
criterion). antagonists, effectiveness or severity of outcomes: >=2 or CCTs.
Patient Antipsychotics, comparisons: patient BPSD* weeks. Harms: RCT,
characteristics second Prescription on validated Depression or CCT,
to be assessed generation drug treatment, tests, anxiety controlled
as possible (any) and first Nonprescription Agitation/ outcomes: >=24 prospective
treatment generation drug treatment, aggression, weeks. cohort studies
effect (only Nondrug Psychosis, >=1,000
modifiers: Age, haloperidol), treatment. Depression, participants,
Sex, Race/ Antidepressants Anxiety, systematic
ethnicity, Pre- , Anti-seizure/ Disinhibited review of any
treatment mood sexual of these study
cognitive or stabilizers, behavior, designs.
functional Anxiolytics, Change in
level/CATD benzodiazepine, patient QoL on
stage, Pre- Anxiolytics, validated test,
treatment BPSD other Hormonal Change in
severity, agents validated
Living setting. (Disinhibited general
sexual behavior behavior scale.
only), Secondary:
Cannabinoids, Change in
Combinations. caregiver/staff
Nonprescription outcomes on
pharmacologic validated
treatment: OTC tests,
supplements, Depression,
Vitamins, Global stress/
Herbals. distress, QOL,
Burden.
Harms:..........
General: FDA
defined
composite SAE
outcome,
Withdrawals due
to AE.
Psychiatric:
Somnolence,
Confusion/
Delirium.
Nonpsychiatric:
Falls,
Extrapyramidal
symptoms,
Stroke,
Mortality (all-
cause, CVD, non-
CVD).
[[Page 64841]]
KQ 7-8: Diagnostic test Cognitive tests: Brief, validated Cognitive tests: Accuracy and Any............ Community- Accuracy and
accuracy & harms (also see Adults >=50 cognitive Full clinical comparative dwelling, comparative
Table 2 below). years of age tests: Global evaluation and/ accuracy (e.g., Assisted accuracy:
with suspected (brief screens, or TP, FP, TN, FN, living. Controlled
CATD. multi-domain neuropsychologi sensitivity, observational
Biomarker tests batteries), cal testing specificity, studies (i.e.,
only: Adults Single domain with explicit PPV, NPV). cross-
>=50 years of tests (memory, diagnostic Of cognitive sectional,
age with executive, criteria. tests for retrospective
clinical language, Biomarker tests: confirming cohort, case
syndrome of attention. Postmortem clinical control);
CATD. Biomarker tests: neuropathologic syndrome of systematic
Patient Brain imaging: al confirmation CATD. review of
characteristics CT/MRI: Medial of AD. Of biomarker controlled
to be assessed temporal tests for observational
as possible atrophy/ confirming that studies.
effect hippocampal etiology of Harms:
modifiers of volume, CATD is AD. Controlled
diagnostic test Cortical Harms:.......... observational
accuracy: Age, thickness, DTI Psychological or studies (i.e.,
Sex, Race/ indices. behavioral. cross-
ethnicity, PET: \18\F-FDG True positive: sectional,
Education, PET, Amyloid Labeling stigma. retrospective
Depression. PET, \11\C-PiB False positive: cohort, case
Pre-test and fluorinated Incorrect control,
cognitive or tracers (e.g. diagnosis, prospective
functional florbetapir, Labeling cohort);
level/CATD flutemetamol, stigma, Side systematic
stage. florbetaben), effects of review of
Tau PET. unneeded controlled
fMRI: Resting interventions observational
state and task (e.g., studies.
specific restrictions on
activation. independence).
SPECT: Resting False negative:
state cerebral Unexplained
perfusion. symptoms,
CSF tests: Failure to make
A[beta]42, appropriate
A[beta]42/ interventions
A[beta]40 (e.g., safety
ratio, t-tau, p- precautions,
tau, t-tau/ future
A[beta]42 planning).
ratio, p-tau/ Any test result:
A[beta]42 Patient or
ratio, caregiver
neurofilament mental distress.
light protein. Physical:
Blood tests: Directly from
A[beta]42, diagnostic
A[beta]42/ tests: Pain,
A[beta]40 Infection,
ratio, APP. Headache,
Combinations.... Radiation.
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* For this report, two psychological symptoms that are components of BPSD have been excluded due to their coverage in recent, high quality systematic
reviews--apathy and sleep disturbances.18 19 In addition, wandering was also eliminated, as this symptom is usually treated with nonpharmacologic
interventions, which are not covered as interventions in this review.
[dagger] Strength of evidence (SOE) will be evaluated for the 1-2 most commonly reported validated treatment efficacy outcomes for each of the following
test categories: disease stage, global cognitive screening tests, global multidomain cognitive tests, memory, executive functioning, language,
attention, function, quality of life, BPSD agitation/aggression, and the harms outcome of serious adverse events. Additional treatment outcomes will
be considered for SOE grading when available data allow. For diagnostic tests, SOE will be graded for the 1-2 most commonly reported validated tests
for each of the following categories: global cognitive screening tests, global multidomain cognitive tests, memory, MRI, PET, and CSF tests.
Additional diagnostic testing outcomes will be considered for SOE grading when available data allow.
A[szlig] = beta amyloid, AD = Alzheimer's dementia, ADL = activities of daily living, AE = adverse events, APOE = apolipoprotein E, APP = amyloid
precursor protein, BPSD = behavioral and psychological symptoms of dementia, CATD = clinical Alzheimer's-type dementia, CCT = controlled clinical
trial, CSF = cerebrospinal fluid, CT = computed tomography, CVD = cardiovascular disease, DTI = diffusion tensor imaging, FDG = fluorodeoxyglucose,
fMRI = functional magnetic resonance imaging, FN = false negative, FP = false positive, IADL = instrumental activities of daily living, MCI = mild
cognitive impairment, MRI = magnetic resonance imaging, NMDA = N-methyl-D-aspartate, NPV = negative predictive value, OTC = over-the-counter, PET =
positron emission tomography, PPV = positive predictive value, p-tau = abnormally phosphorylated tau, QOL = quality of life, RCT = randomized clinical
trial, ROC = receiver operating characteristic, SAE = serious adverse events, SPECT = single-photon emission computed tomography, TN = true negative,
TP = true positive, t-tau = total tau.
[[Page 64842]]
Table 2--Prescription Drugs Used for Treatment of CATD Cognition,
Function, Quality of Life or BPSD
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Class of drug Drug name(s)
------------------------------------------------------------------------
Cholinesterase inhibitor............... Donepezil *, rivastigmine *,
galantamine *.
NMDA receptor antagonist............... Memantine *.
Cholinesterase inhibitor/NMDA receptor Donepezil/Memantine *.
antagonist combination.
1st generation (typical) antipsychotic. only Haloperidol.
2nd generation (atypical) antipsychotic e.g., Risperidone, quetiapine,
olanzapine, aripiprazole,
clozapine.
Anti-depressant, selective serotonin- e.g., Citalopram, escitalopram,
reuptake inhibitor (SSRI). sertraline, fluoxetine,
fluvoxamine, paroxetine.
Anti-depressant, serotonin- e.g., Duloxetine, venlafaxine.
norepinephrine reuptake inhibitor
(SNRI).
Anti-depressant, other [dagger]........ e.g., Trazodone, bupropion,
mirtazapine.
Anti-seizure/mood stabilizer........... e.g., Valproate, gabapentin,
carbamazepine, lamotrigine.
Anti-anxiety, benzodiazepine........... e.g., Clonazepam, diazepam,
lorazepam, temazepam,
alprazolam.
Anti-anxiety, other.................... Buspirone.
Mixed.................................. Dextromethorpan/Quinidine.
Hormones (antiandrogens, estrogens, e.g., medroxyprogesterone
gonadotropin-releasing hormone acetate, cyproterone acetate,
analogues). leuprolide.
Cannabinoids........................... e.g., medical marijuana.
------------------------------------------------------------------------
* US FDA approved indication for Alzheimer's dementia.
[dagger] Excludes MAO-inhibitor, tricyclic and tetracyclic
antidepressants.
BPSD = behavioral and psychological symptoms of dementia, CATD =
clinical Alzheimer's-type dementia, NMDA = N-methyl-D-aspartate, SSRI
= selective serotonin reuptake inhibitor, SNRI = selective
norepinephrine reuptake inhibitor.
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Francis D. Chesley, Jr.,
Acting Deputy Director.
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