CMS-10583 IDEAS Pre-PET form

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)
PRE-PET MEDICAL HISTORY FORM
This form is to be completed by the referring clinician pre-PET. The goal is to validate the items
of the medical history used for the matching paradigm of Aim 2 versus Pre-PET CRF completed
in Aim 1.
Please check all of the following items that are part of the patient’s past medical history:
 Congestive Heart Failure (with or without atrial fibrillation)
 Other Heart Disease (check all that apply)
o Atrial fibrillation
o History an acute myocardial infarction
o Ischemic heart disease (including angina pectoris and/or prior CABG)
o Hypertension
 Chronic Kidney Disease
 Chronic Obstructive Pulmonary Disease
 Diabetes
 Active Depression
 Bipolar Affective Disorder
 Schizophrenia
 Prior History of Stroke and/or Transient Ischemic Attack (within past 24 months)
 Cerebrovascular Disease without Stroke
 Epilepsy/Seizure Disorder
 Parkinson’s Disease
 Multiple Sclerosis
 Traumatic Brain Injury (within past 24 months)

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)
CLINICAL ASSESSMENT FORM (PRE-PET FORM)
This form is intended to capture your diagnosis and management plan prior to amyloid PET.
Please state the diagnosis and management plan you would recommend if amyloid PET were not
available. However, for management items you can state if you wish to defer implementation
pending the results of amyloid PET. After this form is completed, it must be submitted within 7
days to the ACRIN Data Management Center via www.IDEAS-Study.org.
PATIENT CHARACTERISTICS
1. Please specify the level of cognitive impairment:
[ ] Mild cognitive impairment
[ ] Dementia
2. Please enter MMSE or MoCA score at last clinical evaluation:
[ ] MMSE:
[ ] MoCA:
3. Please check all of the following diagnostic procedures that have already been
performed (prior to amyloid PET):
 Basic laboratory work-up (complete metabolic panel, TSH, B12) within last 12
months (required)
 Structural brain imaging (CT or MRI) within past 24 months (required)
 Neuropsychological testing
 Additional serum laboratory tests (e.g. for infectious or
encephalopathies)
 Genetic tests
 Lumbar puncture (check any that apply)
• AD CSF biomarkers (CSF Aβ42, total tau, phosphorylated tau)
• Other CSF studies
 Additional brain imaging (check any that apply)
• FDG-PET
• SPECT- Dopamine transporter (DaTscan)
• SPECT- cerebral perfusion
 Other

auto-immune

4. Please indicate whether the patient is currently taking the following AD medications
(yes/no):
 Cholinesterase inhibitor
 Memantine

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

DIFFERENTIAL DIAGNOSIS
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•

•
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•

5. Please enter the MOST likely etiologic cause of cognitive impairment (select one):
Neurodegenerative:
o Alzheimer’s disease (please specify below):
 AD, clinically typical (memory-predominant)
 AD, clinically atypical (non-amnestic)
 AD, mixed pathology (e.g. mixed vascular, Lewy body, etc.)
 AD, NOS
o Non-AD neurodegenerative (please specify below):
 Vascular cognitive impairment (includes: multi-infarct, subcortical,
intracerebral hemorrhage, other)
 Diffuse Lewy body disease
 Parkinson’s disease
 Frontotemporal dementia (includes behavioral and language-predominant
presentations, corticobasal syndrome and progressive supranuclear paly)
 Hippocampal sclerosis
 Chronic traumatic encephalopathy (CTE)
 Other (allow free text):
Other CNS conditions (please specify below – forced to choose one):
 Hydrocephalus (idiopathic or secondary)
 Epilepsy
 Multiple sclerosis
 Brain mass
 Traumatic brain injury (static)
 Auto-immune encephalopathy (e.g. CNS lupus, cerebral vasculitis, limbic
encephalitis, paraneoplastic syndrome, etc.)
 Infectious encephalopathy (e.g. encephalitis or post-encephalitic encephalopathy,
HIV, neurospyphilis, Lyme disease, etc.)
 Prion disease
 Encephalopathy NOS
 Other (allow free text):
Cognitive changes due to normal aging (no pathological process suspected)
Primary psychiatric disease (please specify below – forced to choose one):
 Major depression
 Bipolar affective disorder
 Schizophrenia
 Other (allow free text):
Toxic-metabolic encephalopathy (please specify below – forced to choose one):
 Substance abuse (alcohol or recreational drugs)
 Polypharmacy or prescription drug side effects
 Primary systemic illness (e.g. hypo/hyperglycemia, CHF, COPD, kidney or liver
failure, hypothyroidism, etc.)

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

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 Hypoxic-ischemic encephalopathy
 Nutritional deficiency (e.g. Vitamin B12, folate, thiamine)
 Other (allow free text):
Primary sleep disorder (e.g. insomnia, sleep apnea, etc.)
Other (allow free text):
6. Please enter at least one (and up to 3) additional items on your current differential
diagnosis:
Neurodegenerative:
o Alzheimer’s disease (please specify below):
 AD, clinically typical (memory-predominant)
 AD, clinically atypical (non-amnestic)
 AD, mixed pathology (e.g. mixed vascular, Lewy body, etc.)
 AD, NOS
o Non-AD neurodegenerative (please specify below):
 Vascular cognitive impairment (includes: multi-infarct, subcortical,
intracerebral hemorrhage, other)
 Diffuse Lewy body disease
 Parkinson’s disease
 Frontotemporal dementia (includes behavioral and language-predominant
presentations, corticobasal syndrome and progressive supranuclear paly)
 Hippocampal sclerosis
 Chronic traumatic encephalopathy (CTE)
 Other (allow free text):
Other CNS conditions (please specify below – forced to choose one):
 Hydrocephalus (idiopathic or secondary)
 Epilepsy
 Multiple sclerosis
 Brain mass
 Traumatic brain injury (static)
 Auto-immune encephalopathy (e.g. CNS lupus, cerebral vasculitis, limbic
encephalitis, paraneoplastic syndrome, etc.)
 Infectious encephalopathy (e.g. encephalitis or post-encephalitic encephalopathy,
HIV, neurospyphilis, Lyme disease, etc.)
 Prion disease
 Encephalopathy NOS
 Other (allow free text):
Cognitive changes due to normal aging (no pathological process suspected)
Primary psychiatric disease (please specify below – forced to choose one):
 Major depression
 Bipolar affective disorder
 Schizophrenia
 Other (allow free text):
Toxic-metabolic encephalopathy (please specify below – forced to choose one):
 Substance abuse (alcohol or recreational drugs)

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

•
•

 Polypharmacy or prescription drug side effects
 Primary systemic illness (e.g. hypo/hyperglycemia, CHF, COPD, kidney or liver
failure, hypothyroidism, etc.)
 Hypoxic-ischemic encephalopathy
 Nutritional deficiency (e.g. Vitamin B12, folate, thiamine)
 Other (allow free text):
Primary sleep disorder (e.g. insomnia, sleep apnea, etc.)
Other (allow free text):
7. Please rate you level of confidence in the PRESENCE of AD pathology
on a scale of 0-10
0

1

2

3

4

5

6

7

8

9

10

MANAGEMENT PLAN
8. Please check all of the following pertaining to your pre-PET management plan (your
intended plan assuming that the patient would not have access to amyloid PET):

MANAGEMENT ACTIONS
(See next table/questions for drug management)
Watchful waiting only
(no new diagnostic tests, drug adjustments,
counseling or referrals)
Counseling for safety, planning & social support
Counseling about safety precautions (home safety,
medication monitoring, driving)
Counseling about financial/medical decision making,
advanced directives
Referral to community patient/caregiver support
resources (e.g. social work, Alzheimer’s Association,
Family caregiver Alliance, etc.)
Other (specify) – free text for pilot testing
Additional diagnostic procedures
Neuropsychological testing referral
Imaging (brain/head)
CT/CTA with/without contrast
MRI/MRA with/without contrast
Brain FDG-PET
DaTscan (Parkinson’s disease)

Recommend

For all checked items:
This item will be
deferred until amyloid
PET result is known
(Y/N)

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)

MANAGEMENT ACTIONS
(See next table/questions for drug management)
SPECT for regional cerebral perfusion
Other imaging (free text for pilot testing)
Laboratory testing (non-imaging)
Lumbar puncture
AD CSF biomarkers (CSF Aβ42, total tau,
phosphorylated tau)
Other CSF studies
Serologic (RPR, HIV, auto-antibodies)
Genetic tests
ApoE genotyping
Autosomal dominant mutations for AD
Autosomal dominant mutations for other conditions
Other testing
EEG
Polysomnography
Other (specify -- free text for pilot testing)
Referral for non-pharmacological interventions
Other specialist (e.g. psychiatrist, sleep medicine)
Surgical intervention (e.g. shunting for
hydrocephalus)
Substance abuse treatment/support programs
Physical, occupational or speech therapy
rehabilitation
Cognitive rehabilitation
Clinical trial referral
AD therapeutic trial (includes amyloid (+) MCI
To non-AD therapeutic trial (please specify)

Recommend

For all checked items:
This item will be
deferred until amyloid
PET result is known
(Y/N)

Mark All Drugs: Therapies that will be started, continued, adjusted, stopped,
or decision deferred until amyloid PET results are known
DRUG DESCRIPTION
AD Symptomatic Drugs
Cholinesterase inhibitors
(donepezil, rivastigmine, galantamine)
Memantine
Non-AD drug modification

STARTED CONTINUED ADJUSTED STOPPED DEFERRED

Imaging Dementia-Evidence for Amyloid Scanning Study Forms (IDEAS)
(version March 31, 2015)
DRUG DESCRIPTION
Anti-depressants, mood stabilizers
Anti-psychotics
Sedatives/sleep aids
Non-neuropsychiatric drugs impacting
cognition
Anti-cholinergic drugs, opiates, muscle
relaxants, etc.
Non-neurology/psychiatric
pharmacologic therapies*
Medical/vascular risk factors
(e.g. anti-platelets, anti-hypertensives,
diabetes medications, lipid lowering,
etc.)
Other neurologic condition
Parkinson’s Disease
Epilepsy
Targeted therapies
Immunosuppressant
(auto-immune/inflammatory
encephalopathy)
Vitamin repletion (nutritional
deficiency)
Antimicrobials (infectious
encephalopathy)

STARTED CONTINUED ADJUSTED STOPPED DEFERRED